Allergenic Extracts

Dosage Form: injection, solution

INSTRUCTIONS Allergenic Extracts FOR INTRADERMAL TESTING

Warnings

This product is intended for use only by physicians who are experienced in the use of Allergenic Extracts, or for use under the guidance of an allergist.

Allergenic Extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use should be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur.

Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing.

This product should never be injected intravenously.

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6

Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections below for further discussion.

Allergenic Extracts Description

Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP™ products; and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of
1. Weight to Volume (w/v)
2. Protein Nitrogen Units/mL (PNU/mL)
3. Allergy Units/mL (AU/mL)
4. Bioequivalent Allergy Units/mL (BAU/mL)
5. Concentrate
  1. Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, APTM (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.
  2. Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.
  3. Allergy Units per mL (AU/mL). The potency of standardized APTM and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.
  4. Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.
  5. Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.

Allergenic Extracts - Clinical Pharmacology

Allergenic Extracts for intradermal testing used according to the DOSAGE AND ADMINISTRATION Section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with the reaction of antigen with IgE on the surface of basophils, or mast cells, which initiates a series of biochemical events resulting in the production of histamine, slow-reacting substance of anaphylaxis and other mediators. These, in turn, produce the immediate-type wheal and flare skin reaction.

Indications and Usage for Allergenic Extracts

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15

In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.

Contraindications

There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regime.

Warnings

Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which he or she is sensitive. Therefore, use caution when applying pollen tests to patients during their active pollen season, or after an exposure to inhalant allergens that produce symptoms. Refer to boxed WARNINGS Section.

Precautions

1. General


It is recommended that disposable syringes and needles are used for intradermal tests to prevent the possibility of accidental transfer of serum hepatitis and other infectious agents from one person to another. Always have injectable epinephrine and a tourniquet available when tests are being made. (See ADVERSE REACTION Section.) Patients should be observed in the office for 30 to 45 minutes after each set of intradermal tests and instructed to return to the office promptly if symptoms of an allergic reaction or shock occur. In order to avoid darkening and possible precipitation, do not dilute the following extracts with solutions containing phenol: Privet pollen and food extracts of White Potato, Corn, Oat, Rye, and Wheat. Injections of such extracts discolored by reaction with phenol may produce lasting tattoo-like discoloration of the skin.

2. Information for Patients

Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 to 45 minute observation period and be warned to return to the office promptly if symptoms occur after leaving.

3. Carcinogenesis, Mutagensis, Impairment of Fertility

Long-term studies in animals have not been conducted with Allergenic Extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

4. Pregnancy

4,5 Pregnancy Category C. Animal reproduction studies have not been conducted with Allergenic Extracts. It is also not known whether Allergenic Extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic Extracts should be given to a pregnant woman only if clearly needed.

5. Nursing Mothers

There are no current studies on secretion of the allergenic extract components in human milk or effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when Allergenic Extracts are administered to a nursing woman.

6. Drug Interactions

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.10Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 10, 11 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.12Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 13

7. Geriatric Use

Skin test wheal size decreases with age. The decrease in allergeninduced skin test reaction parallels that to histamine; therefore, appropriate positive skin test controls should always be performed.1

8. Pediatric Use

Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate postitive control skin tests should always be performed.1

Adverse Reactions

1. Local Reactions
Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.

2. Systemic Reactions
With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that Allergenic Extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering Allergenic Extracts understand and be prepared for the treatment of severe reactions. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8 It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms, in varying degrees of severity, are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.


EPINEPHRINE:

ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, theophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures. [Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986]. Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.

OVERDOSE SECTION

See ADVERSE REACTIONS Section.

Allergenic Extracts Dosage and Administration

1. General
Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2. Intradermal Testing Methods
Cleanse the rubber stopper of the vial with liquid antiseptic before withdrawing extract. A sterile tuberculin syringe with 26-gauge, short-bevel needle should be used for the injection. The anterior surface of the upper and lower arm is preferable for testing. Cleanse the skin with soap and water or wash with alcohol or other antiseptic. Introduce the needle between the superficial layers of the skin and inject 0.02 mL of the extract. Test sites should be at least 2.5 cm apart, and no more than 10 to 20 antigens should be introduced at one time. This group can be followed with additional groups of 10, providing the reactions are not numerous or strong. The same amount of extract should be injected in each site for proper comparison. It is advisable to avoid testing with more than one allergen in the same group in each series, i.e., nuts, fish, epidermals, etc. A site should be injected with 0.02 mL of the control solution. All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests [e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol (0.4%)]. The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract. False positive reactions are sometimes encountered in intradermal testing, and the possibility of irritation reactions should always be taken into consideration. In cases where the patient is known to be quite sensitive, screen testing by scratch, prick or puncture method is recommended, and intradermal testing should be done with caution. The intradermal strength supplied is usually safe for testing patients presenting negative scratch, prick or puncture test reactions. It is recommended that a 1:10 dilution of the stock intradermal strength be used in preliminary testing of patients not previously screened by scratch, prick or puncture tests.

3. Use of Antigen Mixes
The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction it does not indicate which pollen(s) are responsible, and in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.

4. Reading Skin Test Reactions
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient's sensitivity to that allergen.
Standardized Products
(a) Mites: The skin test concentrations of 30 AU/mL and 300 AU/mL in multiple dose vials are used for intradermal testing.
Intradermal skin test results in selected highly sensitive subjects are presented for reference purposes:
AU/mL that Elicited ∑E = 50 mm
Allergen
Number of
Persons
Mean
2 Std. Dev. Range
D. farinae
12
0.0609
0.0015-2.6016
D. pteronyssinus
12
0.333
0.0003-4.0077
Intradermal extracts should be used as follows:
(1) Patients with a negative scratch, prick or puncture test: Patients who do not react to a valid scratch, prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 30 AU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 300 AU/mL extract solution. The negative control used with this latter dilution should contain 0.5% glycerin.
(2) Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.02 to 0.05 mL of a solution containing 0.03 AU/mL. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 300 AU/mL is reached. The negative control used with this latter dilution should contain 0.5% glycerin.
(b) Cat Hair and Cat Pelt: Intradermal endpoint titration (IET) tests were completed with Cat Pelt extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 (D50) mm.That concentration contained 0.042 BAU/mL (range 0.002 to 0.890 BAU/mL).
IET tests were completed with Cat Hair extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 mm (D50). That concentration contained 0.049 BAU/mL (range 0.006 to 0.661 BAU/mL).
Intradermal extract should be used as follows:
Intradermal Tests should be done only on patients with a negative prick or puncture test. Patients who do not react to a valid prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 100 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract solution. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerin.
Standardized Cat Hair and Cat Pelt products are not interchangeable with each other or any other cat products including those labeled AU/mL.
(c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: The intradermal strength for Short Ragweed extract is usually 500 PNU, which by calculation contains approximately 0.7 to 3 units of Antigen E/mL. For Giant and Short Ragweed mix the suggested intradermal strength is 500 PNU, which by calculation contains 0.4 to 1.5 units of Antigen E/mL. These strengths are usually safe for testing patients previously having negative scratch, prick or puncture test reactions. A 1:10 dilution of the stock intradermal strength should be used in preliminary testing of patients not previously screened by scratch, prick, or puncture tests. A study of ragweed sensitive patients9 indicates that intradermal tests, using 0.05 mL of extract, produce positive reactions (1+ to 2+) at Antigen E concentrations of from 2.7x10 -1 to 2.7x10 -6 units per mL. The equivalent PNU range was 100 to 0.001 PNU per mL. Skin tests are graded in terms of the wheal and erythema response noted at 15 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.

5. Geriatric Use

The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

6. Pediatric Use

The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1

Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

Grade
Erythema
mm
Papule or Wheal
mm
Coresponding
mm ∑E
0
<5
<5
<10
±
5-10
5-10
10-20
1+
11-20
5-10
20-40
2+
21-30
5-10
40-60
3+
31-40
10-15 (a)
60-80
4+
>40
>15 (b)
> 80

a or with pseudopods

b or with many pseudopods

A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of year, known exposures, and eating habits.
THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGENIC HISTORY; RATHER, THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

How is Allergenic Extracts Supplied

Most allergens are available in multiple dose 5 mL vials at PNU, w/v, some mixes as Concentrate, Standardized Mite products at AU/mL (30 AU/mL and 300 AU/mL each species), or Standardized Grass products at BAU/mL [100 BAU/mL and 1,000 BAU/mL (Bermuda 100 BAU/mL only)]. Product labels state vials are for intradermal testing and list strengths.

STORAGE

The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° to 8°C, and kept at this temperature range during office use.

LIMITED WARRANTY

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES

1. Middleton, Elliott, Jr., C. E. Reed and E. F. Ellis (Eds.) Allergy Principles and Practice. Vol. 1, C. V. Mosby, 1978.
2. Sheldon, J. M., R. C. Lovell, and K. P. Mathews. A Manual of Clinical Allergy. W. B. Saunders, 1967.
3. Tuft, L. and H. L. Mueller, Allergy in Children. W. B. Saunders, 1979.
4. DuBuske, L.M., C.J. Ling and A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy. Clin. North Am. (USA). 12(1): 145-175, 1992.
5. Weinstein, A. M., D. B. Dubin, W. K. Podleski, L. L. Spector and R. S. Farr. Asthma and pregnancy. JAMA 134(11): 1161-1165, 1979.
6. Jacobs, Robert L., Goeffrey W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127, August 1981.
7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987.
8. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.
9. Norman, P. S., L. M. Lichtenstein, and K. Ishizaka. Diagnostic tests in ragweed hay fever. J. Allergy Clin. Immunol. 52(4): 212-224, 1973.
10. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
11. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79(2): 345-349, February 1987.
12. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.
13. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987.
14. Turkeltaub, Paul C., C. Rastogi Suresh, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized Allergenic Extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986.
15. Food and Drug Administration. Bilogical products; Allergenic Extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220):59228ff, November 16, 1994.
ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER 
ap horse hair and dander injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-4857
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Equus caballus hair (Equus caballus hair) Equus caballus hair 0.0005 g  in 1 mL
Equus caballus dander (Equus caballus dander) Equus caballus dander 0.0005 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-4857-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 01/30/1978
ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER 
cattle hair and dander injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-4813
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bos taurus hair (Bos taurus hair) Bos taurus hair 0.0005 g  in 1 mL
Bos taurus dander (Bos taurus dander) Bos taurus dander 0.0005 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-4813-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 01/30/1978
ANIMAL ALLERGENS, FEATHER MIX 
feather mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-4351
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Gallus gallus Feather (Gallus gallus feather) Gallus gallus Feather 200 [PNU]  in 1 mL
Anas platyrhynchos feather (Anas platyrhynchos feather) Anas platyrhynchos feather 200 [PNU]  in 1 mL
Anser anser feather (Anser anser feather) Anser anser feather 200 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-4351-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
AP HOUSE DUST MIX 
ap house dust mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-4706
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
House Dust (House Dust) House Dust 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-4706-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 08/17/1972
DUST, HOUSE MIXTURE 
dust, house mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-4702
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
House Dust (House Dust) House Dust 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-4702-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
INSECTS (WHOLE BODY) COCKROACH MIX 
insects (whole body) cockroach mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6586
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Periplaneta americana (Periplaneta americana) Periplaneta americana 500 [PNU]  in 1 mL
Blatella germanica (Blatella germanica) Blatella germanica 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-6586-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
INSECTS (WHOLE BODY), FIRE ANT MIX 
insects (whole body), fire ant mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6516
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Solenopsis richteri (Solenopsis richteri) Solenopsis richteri 500 [PNU]  in 1 mL
Solenopsis invicta (Solenopsis invicta) Solenopsis invicta 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-6516-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS - MOLD MIX 10 
molds - mold mix 10 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5138
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alternaria alternata (Alternaria alternata) Alternaria alternata 1000 [PNU]  in 1 mL
Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 1000 [PNU]  in 1 mL
Emericella nidulans (Emericella nidulans) Emericella nidulans 1000 [PNU]  in 1 mL
Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 1000 [PNU]  in 1 mL
Aspergillus terreus (Aspergillus terreus) Aspergillus terreus 1000 [PNU]  in 1 mL
Fusarium oxysporum vasinfectum (Fusarium oxysporum vasinfectum) Fusarium oxysporum vasinfectum 1000 [PNU]  in 1 mL
Dendryphiella vinosa (Dendryphiella vinosa) Dendryphiella vinosa 1000 [PNU]  in 1 mL
Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 1000 [PNU]  in 1 mL
Mucor racemosus (Mucor racemosus) Mucor racemosus 1000 [PNU]  in 1 mL
Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 1000 [PNU]  in 1 mL
Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU]  in 1 mL
Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU]  in 1 mL
Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU]  in 1 mL
Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 1000 [PNU]  in 1 mL
Phoma exigua var. exigua (Phoma exigua var. exigua) Phoma exigua var. exigua 1000 [PNU]  in 1 mL
Aureobasidium pullulans var. pullutans (Aureobasidium pullulans var. pullutans) Aureobasidium pullulans var. pullutans 1000 [PNU]  in 1 mL
Rhizopus stolonifer (Rhizopus stolonifer) Rhizopus stolonifer 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5138-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS - MOLD MIX 4 
molds - mold mix 4 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5001
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alternaria alternata (Alternaria alternata) Alternaria alternata 1000 [PNU]  in 1 mL
Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 1000 [PNU]  in 1 mL
Emericella nidulans (Emericella nidulans) Emericella nidulans 1000 [PNU]  in 1 mL
Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 1000 [PNU]  in 1 mL
Aspergillus terreus (Aspergillus terreus) Aspergillus terreus 1000 [PNU]  in 1 mL
Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 1000 [PNU]  in 1 mL
Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 1000 [PNU]  in 1 mL
Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU]  in 1 mL
Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU]  in 1 mL
Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU]  in 1 mL
Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5001-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS - TRICHOPHYTON MIX 
molds - trichophyton mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5286
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trichophyton tonsurans (Trichophyton tonsurans) Trichophyton tonsurans 1000 [PNU]  in 1 mL
Trichophyton rubrum (Trichophyton rubrum) Trichophyton rubrum 1000 [PNU]  in 1 mL
Trichophyton mentagrophytes (Trichophyton mentagrophytes) Trichophyton mentagrophytes 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5286-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, PENICILLIUM MIX 
molds, penicillium mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5170
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 1000 [PNU]  in 1 mL
Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU]  in 1 mL
Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU]  in 1 mL
Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU]  in 1 mL
Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5170-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS 
alternaria tenuis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5010
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alternaria alternata (Alternaria alternata) Alternaria alternata 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5010-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS 
aspergillus fumigatus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5022
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5022-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS 
candida albicans injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5054
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Candida albicans (Candida albicans) Candida albicans 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5054-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM 
cephalosporium acremonium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5058
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acremonium strictum (Acremonium strictum) Acremonium strictum 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5058-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM 
epicoccum nigrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5102
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epicoccum nigrum (Epicoccum nigrum) Epicoccum nigrum 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5102-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM 
fusarium vasinfectum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5114
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fusarium oxysporum vasinfectum (Fusarium oxysporum vasinfectum) Fusarium oxysporum vasinfectum 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5114-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM 
helminthosporium interseminatum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5126
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dendryphiella vinosa (Dendryphiella vinosa) Dendryphiella vinosa 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5126-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES  
hormodendrum cladosporioides injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5130
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5130-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS 
mucor racemosus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5146
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mucor racemosus (Mucor racemosus) Mucor racemosus 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5146-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM 
penicillium notatum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5210
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5210-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM 
phoma herbarum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5222
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phoma exigua var. exigua (Phoma exigua var. exigua) Phoma exigua var. exigua 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5222-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS 
pullularia pullulans injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5234
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aureobasidium pullulans var. pullutans (Aureobasidium pullulans var. pullutans) Aureobasidium pullulans var. pullutans 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5234-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS 
rhizopus nigricans injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5231
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Rhizopus stolonifer (Rhizopus stolonifer) Rhizopus stolonifer 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5231-1 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM 
stemphylium botryosum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-5266
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pleospora tarda (Pleospora tarda) Pleospora tarda 1000 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-5266-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM 
bahia grass paspalum notatum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1083
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Paspalum notatum pollen (Paspalum notatum pollen) Paspalum notatum pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1083-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE 
johnson grass sorghum halepense injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1746
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sorghum halepense pollen (Sorghum halepense pollen) Sorghum halepense pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1746-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, ACACIA ACACIA LONGIFOLIA 
acacia longifolia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1008
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acacia longifolia pollen (Acacia longifolia pollen) Acacia longifolia pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1008-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, ALDER, RED ALNUS RUBRA 
alder, red alnus rubra injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1020
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alnus rubra pollen (Alnus rubra pollen) Alnus rubra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1020-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA 
ash, white fraxinus americana injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1062
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1062-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, BIRCH MIX  
birch mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1170
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 500 [PNU]  in 1 mL
Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 500 [PNU]  in 1 mL
Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1170-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, BOXELDER/MAPLE MIX 
boxelder/maple mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1215
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 500 [PNU]  in 1 mL
Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 500 [PNU]  in 1 mL
Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1215-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI 
cedar, mountain juniperus ashei injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1338
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Juniperus ashei pollen (Juniperus ashei pollen) Juniperus ashei pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1338-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA 
cedar, red juniperus virginiana injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1341
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Juniperus virginiana pollen (Juniperus virginiana pollen) Juniperus virginiana pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1341-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES 
cottonwood, common populus deltoides injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1437
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1437-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA 
elm, american ulmus americana injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1542
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1542-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA 
elm, chinese ulmus parvifolia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1548
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ulmus parvifolia pollen (Ulmus parvifolia pollen) Ulmus parvifolia pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1548-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS 
hackberry celtis occidentalis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1665
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Celtis occidentalis pollen (Celtis occidentalis pollen) Celtis occidentalis pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1665-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, MAPLE, HARD ACER SACCHARUM 
maple, hard acer saccharum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1833
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1833-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA 
mesquite, prosopis juliflora injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1878
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Prosopis juliflora pollen (Prosopis juliflora pollen) Prosopis juliflora pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1878-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, MULBERRY MIX 
mulberry mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1911
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Morus alba pollen (Morus alba pollen) Morus alba pollen 500 [PNU]  in 1 mL
Morus rubra pollen (Morus rubra pollen) Morus rubra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1911-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, OAK MIX 
oak mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2037
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 500 [PNU]  in 1 mL
Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 500 [PNU]  in 1 mL
Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2037-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, OAK, RED QUERCUS RUBRA 
oak, red quercus rubra injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2016
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2016-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, OLIVE OLEA EUROPAEA 
olive olea europaea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2052
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Olea europaea pollen (Olea europaea pollen) Olea europaea pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2052-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS 
pecan carya carya illinoensis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2100
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2100-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, SYCAMORE, AMERICAN (EASTERN) PLATANUS OCCIDENTALLIS 
sycamore, american (eastern) platanus occidentallis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2565
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2565-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, TREE MIX 11 
tree mix 11 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2621
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 500 [PNU]  in 1 mL
Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 500 [PNU]  in 1 mL
Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 500 [PNU]  in 1 mL
Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 500 [PNU]  in 1 mL
Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 500 [PNU]  in 1 mL
Ulmus Americana pollen (Ulmus Americana pollen) Ulmus Americana pollen 500 [PNU]  in 1 mL
Carya ovata pollen (Carya ovata pollen) Carya ovata pollen 500 [PNU]  in 1 mL
Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 500 [PNU]  in 1 mL
Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 500 [PNU]  in 1 mL
Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 500 [PNU]  in 1 mL
Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2621-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, TREE MIX 5 
tree mix 5 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2857
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 500 [PNU]  in 1 mL
Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 500 [PNU]  in 1 mL
Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 500 [PNU]  in 1 mL
Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 500 [PNU]  in 1 mL
Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 500 [PNU]  in 1 mL
Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 500 [PNU]  in 1 mL
Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 500 [PNU]  in 1 mL
Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 500 [PNU]  in 1 mL
Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2857-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, TREE MIX 6 
tree mix 6 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2860
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 500 [PNU]  in 1 mL
Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 500 [PNU]  in 1 mL
Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 500 [PNU]  in 1 mL
Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 500 [PNU]  in 1 mL
Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 500 [PNU]  in 1 mL
Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 500 [PNU]  in 1 mL
Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 500 [PNU]  in 1 mL
Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2860-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA 
walnut, black juglans nigra injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2628
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2628-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - TREES, WILLOW, BLACK SALIX NIGRA 
willow, black salix nigra injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2679
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2679-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM 
cocklebur xanthium strumarium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1407
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1407-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS 
goldenrod solidago canadensis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1632
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Solidago canadensis pollen (Solidago canadensis pollen) Solidago canadensis pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1632-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, LAMB QUARTERS CHENOPODIUM ALBUM 
lamb quarters chenopodium album injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1788
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1788-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS 
pigweed, rough redroot amaranthus retroflexus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2127
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2127-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA 
plantain, english plantago lanceolata injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2214
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Plantago lanceolata pollen (Plantago lanceolata pollen) Plantago lanceolata pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2214-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA 
ragweed, giant ambrosia trifida injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2295
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ambrosia trifida pollen (Ambrosia trifida pollen) Ambrosia trifida pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2295-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA 
ragweed. western ambrosia psilostachya injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2310
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ambrosia psilostachya pollen (Ambrosia psilostachya pollen) Ambrosia psilostachya pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2310-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI 
russian thistle salsola kali injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2364
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salsola kali pollen (Salsola kali pollen) Salsola kali pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2364-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS 
sagebrush, mugwort artemisia vulgaris injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2415
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Artemisia vulgaris pollen (Artemisia vulgaris pollen) Artemisia vulgaris pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2415-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING (SHAD) ATRIPLEX CANESCENS 
scale, wing (shad) atriplex canescens injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2484
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atriplex canescens pollen (Atriplex canescens pollen) Atriplex canescens pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2484-1 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS, CARELESS/PIGWEED MIX 
careless/pigweed mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1302
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amaranthus palmeri pollen (Amaranthus palmeri pollen) Amaranthus palmeri pollen 500 [PNU]  in 1 mL
Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1302-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS, DOCK/SORREL MIX 
pollens - weeds, dock/sorrel mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1518
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 500 [PNU]  in 1 mL
Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1518-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX 
giant, short, western ragweed mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2319
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ambrosia trifida pollen (Ambrosia trifida pollen) Ambrosia trifida pollen 500 [PNU]  in 1 mL
Ambrosia artemisiifolia pollen (Ambrosia artemisiifolia pollen) Ambrosia artemisiifolia pollen 500 [PNU]  in 1 mL
Ambrosia psilostachya pollen (Ambrosia psilostachya pollen) Ambrosia psilostachya pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2319-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS, KOCHIA SCOPARIA 
kochia scoparia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1782
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Kochia scoparia pollen (Kochia scoparia pollen) Kochia scoparia pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1782-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS, MARSHELDER/POVERTY MIX 
pollens - weeds, marshelder/poverty mix injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-1860
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iva axillaris pollen (Iva axillaris pollen) Iva axillaris pollen 500 [PNU]  in 1 mL
Iva annua var. annua pollen (Iva annua var. annua pollen) Iva annua var. annua pollen 500 [PNU]  in 1 mL
Iva xanthifolia pollen (Iva xanthifolia pollen) Iva xanthifolia pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-1860-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
POLLENS - WEEDS, WEED MIX 2630 
weed mix 2630 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-2631
Route of Administration INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 500 [PNU]  in 1 mL
Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 500 [PNU]  in 1 mL
Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 500 [PNU]  in 1 mL
Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 500 [PNU]  in 1 mL
Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 500 [PNU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
phenol  
sodium chloride  
sodium bicarbonate  
glycerin  
Packaging
# Item Code Package Description
1 NDC:65044-2631-5 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103888 04/19/1941
Labeler - Hollister Stier Laboratories LLC (069263643)
Registrant - Hollister Stier Laboratories LLC (069263643)
Establishment
Name Address ID/FEI Operations
Hollister Stier Laboratories LLC 069263643 manufacture
Revised: 06/2009
 
Hollister Stier Laboratories LLC
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