Pollen Injection

Dosage Form: injection

ALLERGENIC EXTRACT INSTRUCTIONS FOR USE AND DOSAGE SCHEDULE

Warnings

This allergenic product is intended for use by physicians who are experienced in the administration of allergenic extracts, and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.
This allergenic extract is not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from other types of extracts, such as alum precipitated extracts, should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these systemic reactions may occur. In certain individuals these reactions may be life threatening. Patients should be observed for at least 20 minutes following treatment, and emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction.
This product should not be injected intravenously (see Dosage and Administration). Refer also to the Warnings, Precautions, Adverse Reactions and Overdosage sections below.

Pollen Injection Description

Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.

Pollen Injection - Clinical Pharmacology

Positive skin tests with allergenic extract are the result of histamine release from mast cells sensitized with allergen specific IgE. The exact mechanisms by which immunotherapy relieves symptoms of allergy are still under investigation. Elevations in allergen-specific IgG antibodies and an increase in the activity of T suppressor lymphocytes appear to be some of the immunologic changes that occur from hyposensitization.1,2,3

Indications and Usage for Pollen Injection

Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.4,5,6
Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.7-12
Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.

Contraindications

Allergenic extract should not be administered to a non-allergic person. However, there are no absolute contraindications to the use of allergenic extract for treatment in appropriate individuals. Relative contraindications include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; AUTOIMMUNE DISEASE - Individuals with autoimmune disease may be at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease; PREGNANCY - In limited controlled studies of women receiving allergenic extract during conception and throughout all trimesters of pregnancy, no evidence was found that extract is harmful to the fetus or mother. However, because of the known pharmacologic action of histamine on uterine muscle, any treatment that might result in the release of significant amounts of this mediator should be avoided if possible13. See Precaution #4; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may not be able to tolerate immunotherapy. As in all of the above circumstances, the benefit to risk ration must be carefully evaluated; BLEEDING DIATHESIS - Patients with a bleeding tendency should not be tested or treated with allergenic extract, unless the physician responsible believes that such procedures are safe to perform.
Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: (1) severe symptoms of hay fever and/or asthma; (2) infection or flu accompanied by fever; and (3) exposure to excessive amounts of clinically relevant allergens prior to skin testing or immunotherapy.

Warnings

The only approved method for determining hypersensitivity to Allermed Laboratories Allergenic Extracts is by diagnostic skin testing (See DOSAGE AND ADMINISTRATION — DIAGNOSIS).
Physicians who administer allergenic extract should have emergency medication and equipment available to treat anaphylaxis14. See Precautions, Adverse Reactions and Overdosage below.
To reduce the risk of anaphylaxis, the following measures must be observed:

  1. Concentrated extract must be diluted before use for intradermal skin testing and for beginning immunotherapy. It should never be injected intravenously during testing or treatment procedures.
  2. Patients who are highly sensitive, determined from clinical findings and test results, may require that treatment start with a very weak concentration of extract, such as 1:10,000,000 v/v.
  3. The dosage of fresh (new) extract given to a patient receiving maintenance injections must be reduced to one-fourth the amount given from the previous (old) lot (See Immunotherapy, last paragraph).
  4. Patients who are transferred to standardized extract after previous treatment with unstandardized extract must be skin tested with serial dilutions, starting with a 1:100,000 v/v dilution of the standardized extract, to determine a safe, non-reacting starting dose.
  5. Patients who are transferred to this extract after treatment with alum precipitated or other modified extract must re-start injections with the beginning recommended dose of this extract.

Precautions

  1. Extract should be stored at 2°C to 8°C since higher temperatures may adversely affect the stability of the product. Do not freeze.
  2. After the needle is inserted subcutaneously, the plunger should be withdrawn slightly to check for the presence of blood in the syringe. If blood is observed, a new injection should be prepared and given at another site, observing the same precautions.
  3. Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse allergic reaction.
  4. PREGNANCY CATEGORY C. Allergenic extract. Animal reproduction studies have not been conducted with allergenic extract. It is also not known whether allergenic extract can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extract should be given to a pregnant woman only if clearly needed.
  5. PATIENT INSTRUCTIONS: Patients should be instructed to remain in the physician's office for at least 20 minutes after skin testing and after each treatment injection, and immediately notify the physician if symptoms of a generalized reaction or shock occur.
  6. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long term studies have not been conducted with allergenic extracts to determine their potential for carcinogenesis, mutagenesis, and impairment of fertility.
  7. LACTATION: Data are not available on the secretion of allergenic extract in human milk and it is not known what affect this might have on the nursing infant.
  8. PEDIATRIC USE: The dose of allergenic extract recommended for children is the same as that used for adults, except in the injection of large doses of extract for treatment. In this case, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized.

Adverse Reactions

Local Reactions: The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract does not require a reduction in dosage. However, a local reaction with edema larger than 2 cm in diameter or swelling and redness that persist for several hours or longer indicates that too much extract has been given. Treatment should be altered as follows:

  1. Additional injections should not be given until all evidence of the reaction has disappeared.
  2. The next injection administered should be 50% of the last non-reacting dose or less, depending upon the size and severity of the local reaction.
  3. Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result form the administration of a larger dose of extract.

Systemic Reactions:Systemic (generalized) reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis. The reaction usually occurs 5 to 20 minutes after injection. As a rule, the more quickly a reaction develops, the more serious it is likely to become. Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases. The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below). The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts. In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheostomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.
Immunotherapy after anaphylaxis should be continued if the cause of the reaction can be identified and appropriate precautions taken to insure that a subsequent reaction does not occur.

Overdosage

A strong local reaction to the injection of extract may be treated with oral antihistamines and the local application of a cold compress. The dosage must be reduced and additional extract must not be given until all evidence of the reaction has disappeared.
A systemic reaction following the injection of extract must be treated immediately. Reported procedures include (Ref. #4, vol. 2, p. 888):

  1. 0.01 mL/kg up to 0.2 mL of aqueous epinephrine HCL 1:1000 subcutaneously at the injection site of antigen.
  2. 0.01 mL/kg up to 0.3 mL of aqueous epinephrine HCL 1:1000 subcutaneously at another site.
  3. Diphenhydramine intravenously or intramuscularly, 1.25 mg/kg up to 50 mg.
  4. Tourniquet above the injection site of antigen.

Specific reactions:

  1. Brochospasm: intravenous aminophylline 4 mg/kg up to 500 mg given over 10 to 15 minutes, aqueous hydrocortisone 5 mg/kg up to 200 mg, oxygen.
  2. Laryngeal edema: oxygen, intubation, tracheostomy.
  3. Hypotension: vasopressors, fluids, corticosteroids.
  4. Cardiac arrest: resuscitation, sodium bicarbonate, defibrillation, antiarrhythmia medications.

Pollen Injection Dosage and Administration

Diagnosis: Concentrated extract may be used for scratch or prick testing providing the patient is not extremely sensitive. In this case, the extract should be diluted 10 fold before a scratch or prick test is performed. Extract for intradermal testing must be used as follows:

a. Patients with a negative scratch or prick test: Patients who do not react who do not react to a valid scratch or prick test should be tested intradermally with 0.05 mL of a 1:1000 v/v dilution of the concentrate. If the test is negative, a second test should be performed with 0.05 mL of a 1:100 v/v dilution or concentrate.
b. Patients with positive scratch or prick tests: It is not advisable to perform an intradermal skin test if the patient has a positive scratch or prick test.
c. Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.05 mL of a 1:100,000 v/v dilution of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:100 v/v dilution is reached.

Interpretation of Results
Scratch and Prick Test
A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows:

1+ Erythema with 5 mm wheal
2+ Erythema with a 5-10 mm wheal
3+ Erythema with a 10-15 mm wheal
4+ Erythema with a wheal 15 mm (or larger) with pseudopodia

Intradermal Test
A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows:

1+ Erythema 10-20 mm with a 5-10 mm wheal
2+ Erythema 20-30 mm with a 5-10 mm wheal
3+ Erythema 30-40 mm with a 10-15 mm wheal
4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodia

Immunotherapy

Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the risk of anaphylaxis.
Concentrated extract must be diluted before administration to new patients. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. However, as a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5 mm edema/15 mm erythema, the extract is too strong and must be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule (Table 1) below are recommended unless the patient's skin test response and allergic history indicates that more dilute extract should be used.
Little is known about the required accumulated dosage of allergen that is needed to relieve symptoms. However, studies have shown that high dose immunotherapy is efficacious in the treatment of allergic rhinitis and asthma. For this reason, treatment with extract from Vial #5 is recommended, providing the patient can tolerate the extract without experiencing local or systemic reactions. Treatment with Vial #6 may be used for patients who have not had adverse reactions to extract in Vial #5 and who require more concentrated extract to control or relieve symptoms.
Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT OF EXTRACT MADE AT THE SAME CONCENTRATION AND BY THE SAME FORMULA.

Table 1 - Suggested Dosage Schedule
No.
Vial #1
1:100,000 w/v
frequency twice
weekly
mL
Vial #2
1:10,000 w/v
frequency twice
weekly
mL
Vial #3
1:1,000 w/v
frequency once
weekly
mL
Vial #4
1:100 w/v
frequency once
weekly
mL
Vial #5
1:10 w/v
frequency every
two-four weeks
mL
Vial #6
Concentrate
frequency every
two-four weeks
mL
1
0.025
0.025
0.025
0.025
0.025
0.025
2
0.05
0.05 0.05 0.05 0.05 0.05
3
0.10
0.10
0.10
0.10
0.10
0.10
4
0.15
0.15
0.15
0.15
0.15
0.15
5
0.20
0.20
0.20
0.20
0.20
0.20
6
0.25
0.25
0.25
0.25
0.25
0.25
7
0.30
0.30
0.30
0.30
0.30
0.30

SUPPLIED

Allergenic extract is supplied in dropper vials for scratch or prick testing and in 10, 30, and 50 mL vials for bulk use.

WARRANTY

Allermed Laboratories, Inc. certifies that allergenic extract prepared within the Laboratories meets the safety and sterility standards of the F.D.A. Because the Laboratories have no control over the conditions under which extract is sued, or the purposes intended, neither a good nor a bad effect following its administration is warranted.
The users of this product should be aware of the potential dangers involved in the injection of allergenic extract and accept the risk of any consequences resulting from such injections.
No representatives of the Laboratories may change this warranty whether written, oral or implied. The buyer or user must assume full responsibility for the product after it leaves the premises of the Laboratories.

REFERENCES

  1. Levy, D.A., L.M., Lichtenstein, E.O. Goldstein and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigations. 50:360, 1971.
  2. Evans, R., H. Pence, H. Kaplan and R. Rocklin. The effect of immunotherapy on humoral and cellular response in ragweed hayfever. J. Clinical Investigations. 57:1378, 1976.
  3. Ishizaka, K. Cellular events in the IgE antibody response. Adv. In Immunology. 23:50, 1976.
  4. Middleton, Elliott, Jr., C.E. Reed and E.F. Ellis (Eds.) Allergy, Principles and Practice Vols. 1&2, C.V. Mosby 1978.
  5. Sheldon, J.M., R.G. Lovell and K.P. Matthews. A Manual of Clinical Allergy. W.B. Saunders, 1967.
  6. Nelson, H.S. Diagnostic procedures in allergy. I. Allergy skin testing. Ann. Allergy. 51:411, 1983.
  7. Norma, P.S., W.L. Winkenwerder and L.M. Lichtenstein. Immunotherapy of hay fever with ragweed antigen E: comparisons with whole pollen extract and placebos. J. Allergy. 42:93, 1968.
  8. Milner, F.H. and E.C. Tees. Specific sensitivity to individual grass pollens in some hay fever patients. Clinical Allergy. 2:83, 1972.
  9. Frankland, A.W. and R. Augustine. Grass pollen antigens effective in treatment. Clinical Science. 23:95, 1962.
  10. Pence, H.L., D.Q. Mitchell, R.L. Greely, B.R. Updegraff and H.A. Selfridge. Immunotherapy for mountain cedar pollinosis: a double-blind controlled study. J. Allergy ad Clinical Immunology. 58:39, 1976.
  11. Taylor, W.W., J.L. Ohman, Jr. and F.C. Lowell. Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial responses to cat allergen and histamine. J. Allergy and Clinical Immunology. 61:283. 1978.
  12. Lichtenstein, L.M., M.D. Valentine and A.K. Sobotka. Insect allergies. The state of the art. J. Allergy and Clinical Immunology. 61:268, 1978.
  13. Metzger, W.J., E. Turner and R. Patterson. The safety of immunotherapy during pregnancy. J. Allergy and Clinical Immunology. 61:268. 1978.
  14. Ouellette, J.J. Emergency management of allergic reactions. Modern Medicine 99, 1975.
ACACIA POLLEN 
acacia spp. injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-301
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA POLLEN (ACACIA POLLEN) ACACIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-301-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-301-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-301-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-301-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ALDER, WHITE POLLEN 
alnus rhombifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-312
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-312-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-312-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-312-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-312-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ALFALFA POLLEN 
medicago sativa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-300
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDICAGO SATIVA POLLEN (MEDICAGO SATIVA POLLEN) MEDICAGO SATIVA POLLEN 1 g  in 50 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-300-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-300-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-300-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-300-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ALKALI BLITE POLLEN 
suaeda spp. injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-414
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUAEDA MOQUINII POLLEN (SUAEDA MOQUINII POLLEN) SUAEDA MOQUINII POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-414-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-414-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-414-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-414-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ALTERNARIA 
alternaria alternata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-101
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-101-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-101-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-101-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-101-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
AMERICAN ELM POLLEN 
ulmus americana injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-417
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-417-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-417-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-417-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-417-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ARIZONA ASH POLLEN 
fraxinus velutina injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-359
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (FRAXINUS VELUTINA POLLEN) FRAXINUS VELUTINA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-359-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-359-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-359-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-359-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ARROYO WILLOW POLLEN 
salix lasiolepsis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-408
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX LASIOLEPIS POLLEN (SALIX LASIOLEPIS POLLEN) SALIX LASIOLEPIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-408-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-408-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-408-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-408-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ASPEN POLLEN 
populus tremuloides injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-398
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (POPULUS TREMULOIDES POLLEN) POPULUS TREMULOIDES POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-398-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-398-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-398-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-398-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ASPERGILLUS FUMIGATUS 
aspergillus fumigatus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-130
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-130-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-130-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-130-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-130-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
AUSTRALIAN PINE POLLEN 
casuarina equisetifoli injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-335
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (CASUARINA EQUISETIFOLIA POLLEN) CASUARINA EQUISETIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-335-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-335-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-335-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-335-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BAHIA GRASS POLLEN 
paspalum notatum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-384
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASPALUM NOTATUM POLLEN (PASPALUM NOTATUM POLLEN) PASPALUM NOTATUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-384-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-384-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-384-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-384-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BASSIA POLLEN 
bassia hyssopifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-323
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASSIA HYSSOPIFOLIA POLLEN (BASSIA HYSSOPIFOLIA POLLEN) BASSIA HYSSOPIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-323-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-323-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-323-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-323-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BEECH POLLEN 
fagus grandifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-349
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (FAGUS GRANDIFOLIA POLLEN) FAGUS GRANDIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-349-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-349-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-349-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-349-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BLACK COTTONWOOD POLLEN 
populus trichocarpa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-399
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS BALSAMIFERA SSP. TRICHOCARPA POLLEN (POPULUS BALSAMIFERA SSP. TRICHOCARPA POLLEN) POPULUS BALSAMIFERA SSP. TRICHOCARPA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-399-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-399-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-399-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-399-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BLACK OAK POLLEN 
quercus velutina injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-451
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VELUTINA POLLEN (QUERCUS VELUTINA POLLEN) QUERCUS VELUTINA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-451-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-451-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-451-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-451-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BLACK WALNUT POLLEN 
juglans nigra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-366
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-366-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-366-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-366-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-366-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BLACK WILLOW POLLEN 
salix nigra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-409
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) SALIX NIGRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-409-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-409-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-409-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-409-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BOTRYTIS 
botrytis cinerea injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-104
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-104-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-104-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-104-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-104-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BOTTLEBRUSH POLLEN 
callistemon citrinus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-330
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALLISTEMON CITRINUS POLLEN (CALLISTEMON CITRINUS POLLEN) CALLISTEMON CITRINUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-330-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-330-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-330-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-330-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BOX ELDER MAPLE POLLEN 
acer negundo injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-303
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-303-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-303-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-303-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-303-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BURNING BUSH POLLEN 
kochia scoparia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-374
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KOCHIA SCOPARIA POLLEN (KOCHIA SCOPARIA POLLEN) KOCHIA SCOPARIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-374-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-374-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-374-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-374-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BURROBRUSH POLLEN 
hymenoclea salsola injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-362
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYMENOCLEA SALSOLA POLLEN (HYMENOCLEA SALSOLA POLLEN) HYMENOCLEA SALSOLA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-362-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-362-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-362-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-362-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
BURWEED MARSHELDER POLLEN 
iva xanthifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-365
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA XANTHIFOLIA POLLEN (IVA XANTHIFOLIA POLLEN) IVA XANTHIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-365-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-365-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-365-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-365-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CALIF. BLACK WALNUT POLLEN 
juglans californica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-446
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS CALIFORNICA POLLEN (JUGLANS CALIFORNICA POLLEN) JUGLANS CALIFORNICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-446-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-446-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-446-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-446-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CALIFORNIA JUNIPER POLLEN 
juniperus californica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-368
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS CALIFORNICA POLLEN (JUNIPERUS CALIFORNICA POLLEN) JUNIPERUS CALIFORNICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-368-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-368-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-368-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-368-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CALIFORNIA SCRUB OAK POLLEN 
quercus dumosa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-403
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS DUMOSA POLLEN (QUERCUS DUMOSA POLLEN) QUERCUS DUMOSA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-403-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-403-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-403-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-403-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CANARY GRASS POLLEN 
phalaris arundinaceae injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-385
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHALARIS ARUNDINACEA POLLEN (PHALARIS ARUNDINACEA POLLEN) PHALARIS ARUNDINACEA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-385-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-385-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-385-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-385-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CANDIDA 
candida albicans injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-105
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-105-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-105-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-105-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-105-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CANYON RAGWEED POLLEN 
ambrosia ambrosioides injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-352
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA AMBROSIOIDES POLLEN (AMBROSIA AMBROSIOIDES POLLEN) AMBROSIA AMBROSIOIDES POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-352-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-352-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-352-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-352-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CARELESS WEED POLLEN 
amaranthus palmerii injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-313
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS PALMERI POLLEN (AMARANTHUS PALMERI POLLEN) AMARANTHUS PALMERI POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-313-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-313-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-313-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-313-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CATTLE EPITHELIA 
cattle epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-003
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SKIN (BOS TAURUS SKIN) BOS TAURUS SKIN 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-003-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-003-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-003-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-003-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CEPHALOSPORIUM 
cephalosporium roseum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-106
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALOSPORIUM ROSEUM (CEPHALOSPORIUM ROSEUM) CEPHALOSPORIUM ROSEUM 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-106-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-106-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-106-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-106-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CHAETOMIUM 
chaetomium globosum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-107
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-107-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-107-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-107-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-107-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CHEAT GRASS POLLEN 
bromus secalinus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-329
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS SECALINUS POLLEN (BROMUS SECALINUS POLLEN) BROMUS SECALINUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-329-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-329-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-329-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-329-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CHERRY BIRCH POLLEN 
betula lenta injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-442
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (BETULA LENTA POLLEN) BETULA LENTA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-442-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-442-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-442-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-442-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CHINESE ELM POLLEN 
ulmus pumila injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-419
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS PUMILA POLLEN (ULMUS PUMILA POLLEN) ULMUS PUMILA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-419-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-419-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-419-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-419-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CLADOSPORIUM 
cladosporium herbarum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-108
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM HERBARUM (CLADOSPORIUM HERBARUM) CLADOSPORIUM HERBARUM 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-108-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-108-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-108-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-108-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COAST LIVE OAK POLLEN 
quercus agrifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-401
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (QUERCUS AGRIFOLIA POLLEN) QUERCUS AGRIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-401-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-401-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-401-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-401-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COAST MAPLE POLLEN 
acer macrophyllum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-302
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER MACROPHYLLUM POLLEN (ACER MACROPHYLLUM POLLEN) ACER MACROPHYLLUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-302-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-302-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-302-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-302-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COAST SAGE POLLEN 
artemisia californica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-437
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA CALIFORNICA POLLEN (ARTEMISIA CALIFORNICA POLLEN) ARTEMISIA CALIFORNICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-437-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-437-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-437-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-437-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COCKLEBUR POLLEN 
xanthium commune injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-420
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XANTHIUM STRUMARIUM POLLEN (XANTHIUM STRUMARIUM POLLEN) XANTHIUM STRUMARIUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-420-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-420-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-420-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-420-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COCKROACH, AMERICAN 
periplaneta americana injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-047
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERIPLANETA AMERICANA (PERIPLANETA AMERICANA) PERIPLANETA AMERICANA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-047-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-047-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-047-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-047-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COCKROACH, GERMAN 
blattella germanica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-048
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLATELLA GERMANICA (BLATELLA GERMANICA) BLATELLA GERMANICA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-048-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-048-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-048-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-048-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COMMON SAGE POLLEN 
artemisia tridentata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-320
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA TRIDENTATA POLLEN (ARTEMISIA TRIDENTATA POLLEN) ARTEMISIA TRIDENTATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-320-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-320-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-320-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-320-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CORN POLLEN POLLEN 
zea mays injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-422
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZEA MAYS POLLEN (ZEA MAYS POLLEN) ZEA MAYS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-422-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-422-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-422-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-422-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COTTON LINTERS 
cotton linters injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-004
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COTTON FIBER (COTTON FIBER) COTTON FIBER 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-004-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-004-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-004-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-004-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
COTTONSEED 
cottonseed injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-005
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COTTON SEED (COTTON SEED) COTTON SEED 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-005-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-005-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-005-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-005-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CULTIVATED OAT POLLEN 
avena sativa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-322
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVENA SATIVA POLLEN (AVENA SATIVA POLLEN) AVENA SATIVA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-322-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-322-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-322-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-322-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CURVULARIA 
curvularia lunata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-109
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS LUNATUS (COCHLIOBOLUS LUNATUS) COCHLIOBOLUS LUNATUS 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-109-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-109-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-109-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-109-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
CYPRESS, ARIZONA POLLEN 
cupressus arizonica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-341
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN (CUPRESSUS ARIZONICA POLLEN) CUPRESSUS ARIZONICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-341-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-341-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-341-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-341-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
DANDELION POLLEN 
taraxacum officinale injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-416
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-416-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-416-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-416-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-416-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
DATE PALM POLLEN 
phoenix dactylifera injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-387
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOENIX DACTYLIFERA POLLEN (PHOENIX DACTYLIFERA POLLEN) PHOENIX DACTYLIFERA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-387-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-387-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-387-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-387-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
DESERT RAGWEED POLLEN 
ambrosia dumosa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-355
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA DUMOSA POLLEN (AMBROSIA DUMOSA POLLEN) AMBROSIA DUMOSA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-355-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-355-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-355-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-355-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
DOCK, YELLOW POLLEN 
rumex crispus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-406
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX CRISPUS POLLEN (RUMEX CRISPUS POLLEN) RUMEX CRISPUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-406-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-406-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-406-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-406-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
DOG HAIR 
dog hair injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-006
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANIS LUPUS FAMILIARIS HAIR (CANIS LUPUS FAMILIARIS HAIR) CANIS LUPUS FAMILIARIS HAIR 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-006-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-006-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-006-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-006-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
EASTERN COTTONWOOD POLLEN 
populus deltoides injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-395
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-395-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-395-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-395-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-395-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
EASTERN SYCAMORE POLLEN 
platanus occidentalis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-391
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-391-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-391-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-391-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-391-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
EASTERN WHITE PINE POLLEN 
pinus strobus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-388
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (PINUS STROBUS POLLEN) PINUS STROBUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-388-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-388-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-388-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-388-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ENGLISH PLANTAIN POLLEN 
plantago lanceolata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-389
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-389-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-389-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-389-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-389-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ENGLISH WALNUT POLLEN 
juglans regia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-367
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS REGIA POLLEN (JUGLANS REGIA POLLEN) JUGLANS REGIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-367-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-367-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-367-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-367-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
EPICOCCUM 
epicoccum nigrum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-110
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-110-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-110-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-110-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-110-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
EUCALYPTUS POLLEN 
eucalyptus globulus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-347
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (EUCALYPTUS GLOBULUS POLLEN) EUCALYPTUS GLOBULUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-347-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-347-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-347-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-347-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
EUROPEAN OLIVE POLLEN 
olea europea injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-383
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) OLEA EUROPAEA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-383-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-383-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-383-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-383-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
FALSE RAGWEED POLLEN 
ambrosia acanthicarpa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-351
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA ACANTHICARPA POLLEN (AMBROSIA ACANTHICARPA POLLEN) AMBROSIA ACANTHICARPA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-351-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-351-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-351-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-351-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
FLAXSEED 
flaxseed injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-010
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLAX SEED (FLAX SEED) FLAX SEED 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-010-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-010-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-010-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-010-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
FREMONT COTTONWOOD POLLEN 
populus fremontii injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-396
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS FREMONTII POLLEN (POPULUS FREMONTII POLLEN) POPULUS FREMONTII POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-396-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-396-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-396-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-396-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
FUSARIUM 
fusarium solani injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-111
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAEMATONECTRIA HAEMATOCOCCA (HAEMATONECTRIA HAEMATOCOCCA) HAEMATONECTRIA HAEMATOCOCCA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-111-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-111-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-111-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-111-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GAMBELS OAK POLLEN 
quercus gambelii injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-404
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS GAMBELII POLLEN (QUERCUS GAMBELII POLLEN) QUERCUS GAMBELII POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-404-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-404-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-404-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-404-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GIANT RAGWEED POLLEN 
ambrosia trifida injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-317
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) AMBROSIA TRIFIDA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-317-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-317-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-317-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-317-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GLYCEROL-SALINE CONTROL 
glycerol-saline diluent injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-818
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 53 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-818-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-818-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-818-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-818-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GOAT EPITHELIA 
goat epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-011
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPRA HIRCUS SKIN (CAPRA HIRCUS SKIN) CAPRA HIRCUS SKIN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-011-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-011-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-011-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-011-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GRAMA GRASS POLLEN 
bouteloua spp. injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-326
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOUTELOUA GRACILIS POLLEN (BOUTELOUA GRACILIS POLLEN) BOUTELOUA GRACILIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-326-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-326-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-326-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-326-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GRAY (WHITE) BIRCH POLLEN 
betula populifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-325
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA POPULIFOLIA POLLEN (BETULA POPULIFOLIA POLLEN) BETULA POPULIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-325-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-325-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-325-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-325-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GREASEWOOD POLLEN 
sarcobatus vermiculatus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-411
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARCOBATUS VERMICULATUS POLLEN (SARCOBATUS VERMICULATUS POLLEN) SARCOBATUS VERMICULATUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-411-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-411-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-411-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-411-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GREEN ASH POLLEN 
fraxinus pennsylvanica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-358
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS PENNSYLVANICA POLLEN (FRAXINUS PENNSYLVANICA POLLEN) FRAXINUS PENNSYLVANICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-358-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-358-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-358-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-358-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
GUINEA PIG EPITHELIA 
guinea pig epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-012
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAVIA PORCELLUS SKIN (CAVIA PORCELLUS SKIN) CAVIA PORCELLUS SKIN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-012-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-012-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-012-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-012-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HACKBERRY POLLEN 
celtis occidentalis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-336
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (CELTIS OCCIDENTALIS POLLEN) CELTIS OCCIDENTALIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-336-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-336-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-336-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-336-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HAMSTER EPITHELIA 
hamster epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-013
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESOCRICETUS AURATUS SKIN (MESOCRICETUS AURATUS SKIN) MESOCRICETUS AURATUS SKIN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-013-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-013-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-013-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-013-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HARD MAPLE POLLEN 
acer saccharum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-452
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-452-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-452-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-452-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-452-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HAZELNUT POLLEN 
corylus americana injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-340
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (CORYLUS AMERICANA POLLEN) CORYLUS AMERICANA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-340-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-340-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-340-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-340-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HELMINTHOSPORIUM SATIVUM 
helminthosporium sativum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-112
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-112-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-112-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-112-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-112-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HOG EPITHELIA 
hog epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-014
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUS SCROFA SKIN (SUS SCROFA SKIN) SUS SCROFA SKIN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-014-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-014-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-014-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-014-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HORSE EPITHELIA 
horse epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-015
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EQUUS CABALLUS SKIN (EQUUS CABALLUS SKIN) EQUUS CABALLUS SKIN 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-015-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-015-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-015-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-015-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
HOUSE DUST 
house dust injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-008
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOUSE DUST (HOUSE DUST) HOUSE DUST 1 g  in 50 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-008-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-008-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-008-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-008-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
IODINE BUSH POLLEN 
allenrolfea occidentalis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-311
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLENROLFEA OCCIDENTALIS POLLEN (ALLENROLFEA OCCIDENTALIS POLLEN) ALLENROLFEA OCCIDENTALIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-311-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-311-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-311-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-311-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
JOHNSON GRASS POLLEN 
sorghum halepense injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-413
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-413-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-413-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-413-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-413-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
JUTE 
jute injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-016
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORCORUS CAPSULARIS FIBER (CORCORUS CAPSULARIS FIBER) CORCORUS CAPSULARIS FIBER 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-016-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-016-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-016-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-016-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
KAPOK 
kapok injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-017
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEIBA PENTANDRA FIBER (CEIBA PENTANDRA FIBER) CEIBA PENTANDRA FIBER 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-017-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-017-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-017-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-017-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
KARAYA GUM 
karaya gum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-018
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KARAYA GUM (KARAYA GUM) KARAYA GUM 1 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-018-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-018-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-018-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-018-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
KOELERS GRASS POLLEN 
koeleria cristata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-375
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KOELERIA MACRANTHA POLLEN (KOELERIA MACRANTHA POLLEN) KOELERIA MACRANTHA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-375-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-375-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-375-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-375-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
LAMBS QUARTERS POLLEN 
chenopodium album injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-339
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-339-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-339-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-339-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-339-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
LENS SCALE POLLEN 
atriplex lentiformis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-440
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX LENTIFORMIS POLLEN (ATRIPLEX LENTIFORMIS POLLEN) ATRIPLEX LENTIFORMIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-440-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-440-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-440-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-440-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
LINDEN POLLEN 
tilia cordata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-460
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TILIA CORDATA POLLEN (TILIA CORDATA POLLEN) TILIA CORDATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-460-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-460-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-460-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-460-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
LOMBARD POPLAR POLLEN 
populus nigra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-397
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS NIGRA POLLEN (POPULUS NIGRA POLLEN) POPULUS NIGRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-397-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-397-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-397-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-397-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MELALEUCA POLLEN 
melaleuca leucadendron injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-380
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (MELALEUCA QUINQUENERVIA POLLEN) MELALEUCA QUINQUENERVIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-380-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-380-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-380-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-380-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MESQUITE POLLEN 
prosopis juliflora injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-400
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (PROSOPIS JULIFLORA POLLEN) PROSOPIS JULIFLORA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-400-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-400-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-400-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-400-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MONILIA 
monilia sitophila injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-113
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHRYSONILIA SITOPHILA (CHRYSONILIA SITOPHILA) CHRYSONILIA SITOPHILA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-113-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-113-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-113-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-113-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MOUNTAIN CEDAR POLLEN 
juniperus sabinoides injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-371
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (JUNIPERUS ASHEI POLLEN) JUNIPERUS ASHEI POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-371-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-371-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-371-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-371-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MOUSE EPITHELIA 
mouse epithelia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-019
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUS MUSCULUS SKIN (MUS MUSCULUS SKIN) MUS MUSCULUS SKIN 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-019-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-019-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-019-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-019-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MUCOR 
mucor racemosus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-114
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-114-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-114-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-114-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-114-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MUGWORT SAGE POLLEN 
artemisia vulgaris injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-321
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA VULGARIS POLLEN (ARTEMISIA VULGARIS POLLEN) ARTEMISIA VULGARIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-321-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-321-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-321-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-321-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
MUSTARD POLLEN 
brassica campestris injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-327
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRASSICA RAPA POLLEN (BRASSICA RAPA POLLEN) BRASSICA RAPA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-327-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-327-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-327-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-327-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
NETTLE POLLEN 
urtica dioica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-423
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
URTICA DIOICA POLLEN (URTICA DIOICA POLLEN) URTICA DIOICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-423-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-423-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-423-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-423-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ORRIS ROOT 
orris root injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-020
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRIS GERMANICA VAR. FLORENTINA RHIZOME (IRIS GERMANICA VAR. FLORENTINA RHIZOME) IRIS GERMANICA VAR. FLORENTINA RHIZOME 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-020-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-020-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-020-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-020-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PALO VERDE POLLEN 
cercidium torreyana injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-338
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CERCIDIUM FLORIDUM SSP. FLORIDUM POLLEN (CERCIDIUM FLORIDUM SSP. FLORIDUM POLLEN) CERCIDIUM FLORIDUM SSP. FLORIDUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-338-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-338-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-338-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-338-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PECAN POLLEN 
carya illinoinensis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-444
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-444-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-444-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-444-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-444-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PENICILLIUM 
penicillium chrysogenum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-115
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-115-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-115-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-115-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-115-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PEPPER TREE POLLEN 
schinus molle injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-412
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCHINUS MOLLE POLLEN (SCHINUS MOLLE POLLEN) SCHINUS MOLLE POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-412-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-412-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-412-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-412-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PHOMA 
phoma betae injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-116
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLEOSPORA BETAE (PLEOSPORA BETAE) PLEOSPORA BETAE 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-116-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-116-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-116-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-116-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
POVERTY WEED POLLEN 
iva axillaris injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-363
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA AXILLARIS POLLEN (IVA AXILLARIS POLLEN) IVA AXILLARIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-363-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-363-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-363-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-363-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PRIVET POLLEN 
ligustrum vulgare injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-376
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (LIGUSTRUM VULGARE POLLEN) LIGUSTRUM VULGARE POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-376-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-376-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-376-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-376-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PULLULARIA 
pullularia pullulans injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-117
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-117-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-117-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-117-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-117-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
PUSSY WILLOW POLLEN 
salix discolor injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-407
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX DISCOLOR POLLEN (SALIX DISCOLOR POLLEN) SALIX DISCOLOR POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-407-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-407-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-407-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-407-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
QUACKGRASS POLLEN 
agropyron repens injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-307
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELYMUS REPENS POLLEN (ELYMUS REPENS POLLEN) ELYMUS REPENS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-307-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-307-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-307-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-307-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RABBITBUSH POLLEN 
ambrosia deltoides injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-354
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA DELTOIDEA POLLEN (AMBROSIA DELTOIDEA POLLEN) AMBROSIA DELTOIDEA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-354-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-354-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-354-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-354-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RED ALDER POLLEN 
alnus rubra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-435
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS RUBRA POLLEN (ALNUS RUBRA POLLEN) ALNUS RUBRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-435-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-435-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-435-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-435-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RED CEDAR POLLEN 
juniperus virginiana injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-373
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-373-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-373-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-373-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-373-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RED MAPLE POLLEN 
acer rubrum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-434
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-434-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-434-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-434-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-434-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RED MULBERRY POLLEN 
morus rubra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-447
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) MORUS RUBRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-447-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-447-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-447-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-447-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RED OAK POLLEN 
quercus rubra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-450
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS RUBRA POLLEN (QUERCUS RUBRA POLLEN) QUERCUS RUBRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-450-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-450-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-450-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-450-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
REDROOT PIGWEED POLLEN 
amaranthus retroflexus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-314
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-314-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-314-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-314-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-314-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RHIZOPUS 
rhizopus oryzae injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-118
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS ARRHIZUS VAR. ARRHIZUS (RHIZOPUS ARRHIZUS VAR. ARRHIZUS) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-118-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-118-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-118-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-118-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RIVER/RED BIRCH POLLEN 
betula nigra injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-443
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-443-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-443-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-443-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-443-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ROCKY MTN. JUNIPER POLLEN 
juniperus scopulorum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-372
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS SCOPULORUM POLLEN (JUNIPERUS SCOPULORUM POLLEN) JUNIPERUS SCOPULORUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-372-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-372-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-372-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-372-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
ROUGH MARSHELDER POLLEN 
iva ciliata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-364
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVA ANNUA VAR. ANNUA POLLEN (IVA ANNUA VAR. ANNUA POLLEN) IVA ANNUA VAR. ANNUA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-364-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-364-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-364-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-364-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RUSSIAN OLIVE POLLEN 
elaeagnus angustifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-346
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELAEAGNUS ANGUSTIFOLIA POLLEN (ELAEAGNUS ANGUSTIFOLIA POLLEN) ELAEAGNUS ANGUSTIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-346-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-346-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-346-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-346-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RUSSIAN THISTLE POLLEN 
salsola kali injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-410
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) SALSOLA KALI POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-410-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-410-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-410-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-410-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
RUST, WHEAT 
puccinia striiformis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-120
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PUCCINIA STRIIFORMIS VAR. STRIIFORMIS (PUCCINIA STRIIFORMIS VAR. STRIIFORMIS) PUCCINIA STRIIFORMIS VAR. STRIIFORMIS 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-120-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-120-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-120-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-120-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SALT CEDAR POLLEN 
tamarix gallica injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-415
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMARIX GALLICA POLLEN (TAMARIX GALLICA POLLEN) TAMARIX GALLICA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-415-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-415-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-415-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-415-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SALT GRASS POLLEN 
distichlis spicata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-345
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISTICHLIS SPICATA POLLEN (DISTICHLIS SPICATA POLLEN) DISTICHLIS SPICATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-345-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-345-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-345-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-345-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SANDBUR RAGWEED POLLEN 
ambrosia bipinnatifida injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-353
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA CHAMISSONIS POLLEN (AMBROSIA CHAMISSONIS POLLEN) AMBROSIA CHAMISSONIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-353-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-353-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-353-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-353-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SHAD SCALE POLLEN 
atriplex confertifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-439
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX CONFERTIFOLIA POLLEN (ATRIPLEX CONFERTIFOLIA POLLEN) ATRIPLEX CONFERTIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-439-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-439-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-439-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-439-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SHAGBARK HICKORY POLLEN 
carya ovata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-332
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-332-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-332-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-332-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-332-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SHEEP SORREL POLLEN 
rumex acetosella injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-405
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUMEX ACETOSELLA POLLEN (RUMEX ACETOSELLA POLLEN) RUMEX ACETOSELLA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-405-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-405-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-405-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-405-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SHORTLEAF PINE POLLEN 
pinus echinata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-448
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ECHINATA POLLEN (PINUS ECHINATA POLLEN) PINUS ECHINATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-448-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-448-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-448-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-448-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SILVER MAPLE POLLEN 
acer saccharinum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-304
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-304-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-304-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-304-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-304-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SILVER RAGWEED POLLEN 
dicoria canescens injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-344
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICORIA CANESCENS POLLEN (DICORIA CANESCENS POLLEN) DICORIA CANESCENS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-344-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-344-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-344-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-344-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SISAL 
sisal injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-021
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGAVE SISALANA FIBER (AGAVE SISALANA FIBER) AGAVE SISALANA FIBER 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-021-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-021-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-021-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-021-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SLENDER RAGWEED POLLEN 
ambrosia tenuifolia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-356
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA TENUIFOLIA POLLEN (AMBROSIA TENUIFOLIA POLLEN) AMBROSIA TENUIFOLIA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-356-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-356-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-356-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-356-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SMOOTH BROME POLLEN 
bromus inermis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-328
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMUS INERMIS POLLEN (BROMUS INERMIS POLLEN) BROMUS INERMIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-328-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-328-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-328-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-328-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SMUT, CORN 
ustilago maydis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-122
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO MAYDIS (USTILAGO MAYDIS) USTILAGO MAYDIS 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-122-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-122-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-122-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-122-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SMUT, JOHNSON GRASS 
sphacelotheca cruenta injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-123
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-123-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-123-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-123-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-123-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SMUT, WHEAT 
tilletia caries (tritici) injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-124
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TILLECIA CARIES (TILLECIA CARIES) TILLECIA CARIES 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-124-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-124-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-124-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-124-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SPRING BIRCH POLLEN 
betula fontinalis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-441
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA OCCIDENTALIS POLLEN (BETULA OCCIDENTALIS POLLEN) BETULA OCCIDENTALIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-441-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-441-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-441-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-441-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
STEMPHYLIUM 
stemphylium botryosum injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-126
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLEOSPORA TARDA (PLEOSPORA TARDA) PLEOSPORA TARDA 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-126-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-126-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-126-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-126-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SUGAR BEET POLLEN 
beta vulgaris injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-324
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA VULGARIS POLLEN (BETA VULGARIS POLLEN) BETA VULGARIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-324-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-324-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-324-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-324-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SUNFLOWER POLLEN 
helianthus annua injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-360
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIANTHUS ANNUUS POLLEN (HELIANTHUS ANNUUS POLLEN) HELIANTHUS ANNUUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-360-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-360-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-360-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-360-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
SWEET GUM POLLEN 
liquidamber styraciflua injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-377
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (LIQUIDAMBAR STYRACIFLUA POLLEN) LIQUIDAMBAR STYRACIFLUA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-377-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-377-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-377-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-377-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
TAG ALDER POLLEN 
alnus rugosa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-436
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SSP. RUGOSA POLLEN (ALNUS INCANA SSP. RUGOSA POLLEN) ALNUS INCANA SSP. RUGOSA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-436-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-436-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-436-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-436-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
TOBACCO LEAF 
tobacco leaf injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-022
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBACCO LEAF (TOBACCO LEAF) TOBACCO LEAF 1 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-022-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-022-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-022-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-022-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
TREE OF HEAVEN POLLEN 
ailanthus altissima injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-310
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AILANTHUS ALTISSIMA POLLEN (AILANTHUS ALTISSIMA POLLEN) AILANTHUS ALTISSIMA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-310-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-310-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-310-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-310-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
UTAH JUNIPER POLLEN 
juniperus osteosperma injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-370
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS OSTEOSPERMA POLLEN (JUNIPERUS OSTEOSPERMA POLLEN) JUNIPERUS OSTEOSPERMA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-370-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-370-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-370-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-370-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
VELVET GRASS POLLEN 
holcus lanatus injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-361
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOLCUS LANATUS POLLEN (HOLCUS LANATUS POLLEN) HOLCUS LANATUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-361-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-361-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-361-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-361-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WESTERN JUNIPER POLLEN 
juniperus occidentalis injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-369
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS OCCIDENTALIS POLLEN (JUNIPERUS OCCIDENTALIS POLLEN) JUNIPERUS OCCIDENTALIS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-369-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-369-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-369-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-369-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WESTERN RAGWEED POLLEN 
ambrosia psilostachia injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-316
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMBROSIA PSILOSTACHYA POLLEN (AMBROSIA PSILOSTACHYA POLLEN) AMBROSIA PSILOSTACHYA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-316-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-316-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-316-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-316-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WESTERN SYCAMORE POLLEN 
platanus racemosa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-392
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS RACEMOSA POLLEN (PLATANUS RACEMOSA POLLEN) PLATANUS RACEMOSA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-392-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-392-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-392-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-392-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WESTERN WATERHEMP POLLEN 
acnida tamariscina injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-305
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS TUBERCULATUS POLLEN (AMARANTHUS TUBERCULATUS POLLEN) AMARANTHUS TUBERCULATUS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-305-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-305-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-305-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-305-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WESTERN WHEATGRASS POLLEN 
agropyron smithii injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-308
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASCOPYRUM SMITHII POLLEN (PASCOPYRUM SMITHII POLLEN) PASCOPYRUM SMITHII POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-308-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-308-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-308-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-308-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WHITE ASH POLLEN 
fraxinus americana injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-357
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-357-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-357-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-357-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-357-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WHITE HICKORY POLLEN 
carya tomentosa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-334
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-334-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-334-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-334-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-334-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WHITE MULBERY POLLEN 
morus alba injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-382
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS ALBA POLLEN (MORUS ALBA POLLEN) MORUS ALBA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-382-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-382-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-382-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-382-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WHITE OAK POLLEN 
quercus alba injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-402
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-402-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-402-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-402-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-402-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WHITE POPLAR POLLEN 
populus alba injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-394
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-394-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-394-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-394-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-394-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WING SCALE POLLEN 
atriplex canescens injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-438
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATRIPLEX CANESCENS POLLEN (ATRIPLEX CANESCENS POLLEN) ATRIPLEX CANESCENS POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-438-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-438-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-438-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-438-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WINTERFAT POLLEN 
eurotia lanata injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-348
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KRASCHENINNIKOVIA LANATA POLLEN (KRASCHENINNIKOVIA LANATA POLLEN) KRASCHENINNIKOVIA LANATA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-348-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-348-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-348-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-348-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
WORMWOOD SAGE POLLEN 
artemisia absinthium injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-319
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARTEMISIA ABSINTHIUM POLLEN (ARTEMISIA ABSINTHIUM POLLEN) ARTEMISIA ABSINTHIUM POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-319-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-319-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-319-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-319-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
YELLOW PINE POLLEN 
pinus ponderosa injection
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:49643-449
Route of Administration INTRADERMAL, CUTANEOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS PONDEROSA POLLEN (PINUS PONDEROSA POLLEN) PINUS PONDEROSA POLLEN 1 g  in 20 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 0.25 g  in 100 mL
Sodium Bicarbonate 0.125   in 100 mL
Glycerin 53 mL  in 100 mL
Phenol 0.4 g  in 100 mL
Water  
Packaging
# Item Code Package Description
1 NDC:49643-449-05 5 mL in 1 VIAL, MULTI-DOSE
2 NDC:49643-449-10 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:49643-449-30 30 mL in 1 VIAL, MULTI-DOSE
4 NDC:49643-449-50 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102212 03/12/1974
Labeler - Allermed Laboratories, Inc. (073364531)
Establishment
Name Address ID/FEI Operations
Allermed Laboratories, Inc. 073364531 manufacture
Revised: 05/1986
 
Allermed Laboratories, Inc.
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