Allergenic Extracts, Pollen

Dosage Form: injection, solution

Allergenic Extract

Warnings

Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis. This 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 switching from other types of extracts to Antigen Laboratories’ allergenic extracts should be started as if they were undergoing treatment for the first time. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%.

Severe systemic reactions may occur with all allergenic extracts. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Patients should be observed for at least 20 minutes following allergenic extract injections. Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections below.

Allergenic Extracts, Pollen Description

Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.

FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:

INACTIVE INGREDIENTS:

Sodium chloride…………………………………………………………….0.95%

Sodium bicarbonate………………………………………………………..0.24%

Glycerine…………………………………………………………………50% (v/v)

Water for Injection…………………………………………………q.s. to volume

Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular.

Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v).

Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.

Allergenic Extracts, Pollen - Clinical Pharmacology

Studies indicate allergic individuals produce immunoglobulins of the IgE class in response to exposure to allergens. Subsequent exposure to the allergen results in a combination of allergen with IgE antibody fixed on mast cells or basophil membranes. This cross-linking results in stimulation of mast cell which leads to release and generation of pharmacologically active substances that produce immediate hypersensitivity reaction.3

The mode of action of immunotherapy with allergenic extracts is still under investigation. Subcutaneous injections of increasing doses of allergenic extract into patients with allergic disease have been shown to result in both humoral and cellular changes including the production of allergen-specific IgG antibodies, the suppression of histamine release from target cells, decrease in circulating levels of antigen specific IgE antibody over long periods of time and suppression of peripheral blood T-lymphocyte cell responses to antigen.10, 14, 15

Indications and Usage for Allergenic Extracts, Pollen

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.

Contraindications

Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.

Warnings

Refer to boxed “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections for additional information on serious adverse reactions and steps to be taken, if any occur.

Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients who have experienced severe symptoms or anaphylaxis by natural exposure, or during previous skin testing or treatment. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT’S SENSITIVITY AND TOLERANCE.

Benefit versus risk needs to be evaluated in steroid dependent asthmatics, patients with unstable asthma or patients with underlying cardiovascular disease.

Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. Withdraw plunger slightly after inserting needle to determine if a blood vessel has been entered.

Proper measurement of dose and caution in making injection will minimize reactions. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy.

Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patient’s immunotherapy program.

Precautions

General:

Immunotherapy must be given under physician’s supervision. Sterile solutions, vials, syringes, etc. must be used. Aseptic technique must be observed in making dilutions from stock concentrates. The usual precautions in administering allergenic extracts are necessary, refer to boxed WARNINGS and “WARNINGS” section. Sterile syringe and needle must be used for each individual patient to prevent transmission of serum hepatitis, Human Immunodeficiency Virus (HIV) and other infectious agents.

Epinephrine 1:1000 should be available. Refer to “OVERDOSAGE” section for description of treatment for anaphylactic reactions.

Information for Patients:

Patient should remain under observation of a nurse, physician, or personnel trained in emergency measures for at least 20 minutes following immunotherapy injection. Patient must be instructed to report any adverse reactions that occur within 24 hours after injection. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. Immediate medical attention must be sought for reactions that occur during or after leaving physician’s office.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

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

Pregnancy Category C:

Animal reproduction studies have not been conducted with allergenic extracts. It is not known whether allergenic extracts cause fetal harm during pregnancy or affect reproductive capacity. A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. Allergenic extracts should be used during pregnancy only if potential benefit justifies potential risk to fetus.11

Nursing Mothers:

It is not known whether allergenic extracts are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

Pediatric Use:

Allergenic extracts have been used routinely in children, and no special safety problems or specific hazards have been found. Children can receive the same dose as adults. Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17

Drug Interactions:

Antihistamines. Antihistamines inhibit the wheal and flare reaction. The inhibitory effect of conventional antihistamines varies from 1 day up to 10 days, according to the drug and patient’s sensitivity. Long acting antihistamines (e.g., astemizole) may inhibit the wheal and flare for up to forty days.1, 2

Imipramines, phenothiazines, and tranquilizers. Tricyclic antidepressants exert a potent and sustained decrease of skin reactions to histamine. This effect may last for a few weeks. Tranquilizers and antiemetic agents of the phenothiazine class have H1 antihistaminic activity and can block skin tests.1

Corticosteroids. Short-term (less than 1 week) administration of corticosteroids at the therapeutic doses used in asthmatic patients does not modify the cutaneous reactivity to histamine, compound 48/80, or allergen. Long-term corticosteroid therapy modifies the skin texture and makes the interpretation of immediate skin tests more difficult.1

Theophylline. It appears that theophylline need not be stopped prior to skin testing.1

Beta-Blockers. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.1

Beta-adrenergic agents. Inhaled beta2 agonists in the usual doses used for the treatment of asthma do not usually inhibit allergen-induced skin tests. However, oral terbutaline and parenteral ephedrine were shown to decrease the allergen-induced wheal.1

Cromolyn. Cromolyn inhaled or injected prior to skin tests with allergens or degranulating agents does not alter skin whealing response.1

Other drugs. Other drugs have been shown to decrease skin test reactivity. Among them, dopamine is the best-documented compound.1

Specific Immunotherapy. A decreased skin test reactivity has been observed in patients undergoing specific immunotherapy with pollen extracts, grass pollen allergoids, mites, hymenoptera venoms, or in professional beekeepers who are spontaneously desensitized. Finally, it was shown that specific immunotherapy in patients treated with ragweed pollen extract induced a decreased late-phase reaction.1

Adverse Reactions

Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing.

1) Local Reactions

A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.

Small amounts of erythema and swelling at the site of injection are common. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter.

Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing.

Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or use of oral antihistamines.

2) Systemic Reactions

Systemic reactions range from mild exaggeration of patient’s allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14

Careful attention to dosage and administration limit such reactions. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. Refer to “OVERDOSAGE” section.

Overdosage

Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections for signs and symptoms of an overdose.

If a systemic or anaphylactic reaction does occur, apply tourniquet above the site of allergenic extract injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 Epinephrine-hydrochloride into the opposite arm or gluteal area. Repeat dose in 5-10 minutes if necessary. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. Discontinue use of the tourniquet after ½ hour.

The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Symptoms of progressive anaphylaxis include airway obstruction and/or vascular collapse. After administration of epinephrine, profound shock and vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Monitor airways for obstruction. Oxygen should be given by mask if indicated.

Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4

Patients who have been taking beta-blockers may be unresponsive to epinephrine. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. These drugs should be administered even though a beta-blocker may have been taken. The following treatment will be effective whether or not patient is taking a beta-blocker: Aminophylline IV, slow push or drip, Atrovent (Ipratropium bromide) Inhaler, 3 inhalations repeated, Atropine, 0.4 mg/ml, 0.75 to 1.5 ml IM or IV, Solu-Cortef, 100-200 mg IM or IV, Solu-Medrol, 125 mg IM or IV, Glucagon, 0.5-1 mg IM or IV, Benadryl, 50 mg IM or IV, Cimetidine, 300 mg IM or IV, Oxygen via ambu bag.

Allergenic Extracts, Pollen Dosage and Administration

Refer to “STORAGE” section for proper storage condition for allergenic extract. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some allergenic extracts naturally precipitate.

Physicians undertaking immunotherapy should be concerned with patient’s degree of sensitivity. The initial dilution of allergenic extract, starting dose, and progression of dosage must be carefully determined on the basis of the patient’s history and results of skin tests. Strongly positive skin tests may be risk factors for systemic reactions. Less aggressive immunotherapy schedules may be indicated for such patients.

Precaution is necessary when using extract mixture for skin testing. The diluting effect of individual components within a mixture may cause false negative reactions. Patients extremely sensitive to a common allergen in several components of a mixture may be more likely to experience a systemic reaction than when skin tested individually for each component.9

PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intradermally with an appropriately diluted extract.

A positive control using histamine phosphate identifies patients whose skin may not react due to medications, metabolic or other reasons. A negative control (50% glycerine for prick-puncture testing) would exclude false-positive reactions due to ingredients in diluent or patients who have dermatographism.

SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions, five-fold or ten-fold, may be prepared from stock concentrate using physiologic saline as a diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, or a negative or weakly reactive prick-puncture test, the initial dilution for skin testing should be a dilution at least 1:12,500 w/v. This initial dilution can be prepared by diluting 1:20 to 1:50 w/v (2%-5%) extracts five-fold to 5-4 or 1:10 w/v (10%) extracts to 5-5. See “Serial Dilutions Titration Test Dilutions” chart on the next page. Dilute 1:10 w/v (10%) extracts to 10-3 if using ten-fold dilutions. (4) Sensitive patients with a positive prick-puncture test require a further dilution to at least 1:312,500 w/v. This dilution can be prepared by diluting 1:20 to 1:50 w/v (2% - 5%) extracts to 5-6 or 1:10 w/v (10%) extracts to 5-7 (five-fold dilutions). Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. Size of reactions are quantitated based on size of wheal and erythema. For interpretation of skin reactions, refer to chart below. If after 20 minutes no skin reaction is observed, continue testing using increasing increments of the concentration until a reaction of 5-10 mm wheal and 11-30 mm erythema is obtained, or a concentration of 5-2 or 10-1 has been tested. A negative control, 50% glycerine diluted with diluent to 5-2 (1:25) or 10-1 (1:10) dilution and a positive control of histamine phosphate, should be tested and included in interpretation of skin reactions.1, 13

GRADE mm ERYTHEMA mm WHEAL
0 less than 5 less than 5
± 5-10 5-10
1+ 11-20 5-10
2+ 21-30 5-10
3+ 31-40 10-15 or with pseudopods
4+ greater than 40 greater than 15 or with many pseudopods

INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient’s degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. For patients demonstrating a negative or weakly reactive prick-puncture skin test, an initial screening dilution of 1:12,500 w/v is safe. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. (See “Serial Dilution Titration Test Dilutions” chart below.) When a sequence of five-fold or ten-fold dilutions of an allergen are injected, the endpoint is determined by noting the dilution that first produces a wheal and erythema (15 minutes after injection) that is 2 mm larger than wheals with erythema produced by weaker, non-reacting dilutions (5 mm negative wheal). The endpoint dilution is used as a starting dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each individual.

Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection.

IMMUNOTHERAPY: If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.6

Some patients may tolerate larger doses of the allergenic extract depending on patient response.7 Because diluted extract tends to lose activity in storage, the first dose from a more concentrated vial should be the same, or less than, the previous dose.8, 12

Dosages progressively increase according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief from symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose is reached (the largest dose tolerated by the patient that relieves symptoms without undesirable local or systemic reactions). This maintenance dose may be continued at regular intervals perennially. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions.

The usual duration of treatment has not been established. A period of two or three years on immunotherapy constitutes an average minimum course of treatment.

SERIAL DILUTION TITRATION TEST DILUTIONS APPROXIMATE ALLERGENIC EXTRACT CONCENTRATION RESULTING FROM 1:5 DILUTION
Titration Number Dilution Exponent Weight / Volume Allergenic Extract Concentrate
1:50 (2%) 1:40 (2 1/2%) 1:33 1/3 (3%) 1:20 (5%) 1:10 (10%)
No. 1 5-1 1:5 1:250 1:200 1:167 1:100 1:50
No. 2 5-2 1:25 1:1,250 1:1,000 1:835 1:500 1:250
No. 3 5-3 1:125 1:6,250 1:5,000 1:4,175 1:2,500 1:1,250
No. 4 5-4 1:625 1:31,250 1:25,000 1:20,875 1:12,500 1:6,250
No. 5 5-5 1:3,125 1:156,250 1:125,000 1:104,375 1:62,500 1:31,250
No. 6 5-6 1:15,625 1:781,250 1:625,000 1:521,875 1:312,500 1:156,250
No. 7 5-7 1:78,125 1:3,906,250 1:3,125,000 1:2,609,375 1:1,562,500 1:781,250
No. 8 5-8 1:390,625 1:19,531,250 1:15,625,000 1:13,046,875 1:7,812,500 1:3,906,250
No. 9 5-9 1:1,953,125 1:97,656,250 1:78,125,000 1:65,234,375 1:39,062,500 1:19,531,250
No. 10 5-10 1:9,765,625 1:488,281,250 1:390,625,000 1:326,171,875 1:195,312,500 1:97,656,250
No. 11 5-11 1:48,828,125 1:2,441,406,250 1:1,953,125,000 1:1,630,859,375 1:976,562,500 1:488,281,250
No. 12 5-12 1:244,140,625 1:12,207,031,250 1:9,765,625,000 1:8,154,296,875 1:4,882,812,500 1:2,441,406,250

How is Allergenic Extracts, Pollen Supplied

Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio.

Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content.

Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.

STORAGE

Store all stock concentrates and dilutions at 2-8° C. Keep at this temperature during office use. The expiration date of the allergenic extracts is listed on the container label. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.

REFERENCES

1. Bousquet, Jean: “In vivo methods for study of allergy: Skin tests” Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I, Chap. 19, pp 419-436, 1988.

2. Long, W.F., Taylor, R.J., Wagner, C.J., et al.: Skin test suppression by antihistamines and the development of subsensitivity, J. Allergy Clin. Immunol., pp. 76-113, 1985.

3. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp 135-163, 1988.

4. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 1, Chap. 58, pp. 1365-1376, 1988.

5. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas. “Survey of Fatalities from Skin Testing and Immunotherapy 1985-1989”, Journal of Allergy and Clinical Immunology, Vol. 92, No. 1, pp. 6-15, 1993.

6. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.

7. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. I, Chap. 4, p. 52, edited by Middleton et al.

8. Nelson, H.S.: “The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract.” The Journal of Allergy and Clinical Immunology, Vol. 63, No. 6, pp. 417-425, June 1979.

9. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 84-86.

10. Rocklin, R.E., Sheffer, A.L., Grainader, D.K. and Melmon, K.: “Generation of antigen-specific suppressor cells during allergy desensitization”, New England Journal of Medicine, 302, May 29, 1980, pp. 1213-1219.

11. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp 9-48.

12. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.

13. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: “A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever,“ The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, p. 511, December 1980.

14. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast Cell-its role in Health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

15. Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. Annals of Allergy, Vol. 57, August 1986.

16. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. J. Dis. Child., pp. 123-222, 1972.

17. Willoughby, J.W.: Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988.

CONTAINER LABELING

WESTERN BLACK WILLOW 
western black willow injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0606
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX LUCIDA SSP. LASIANDRA POLLEN (SALIX LUCIDA SSP. LASIANDRA POLLEN) SALIX LUCIDA SSP. LASIANDRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0606-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0606-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0606-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0606-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0606-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ENGLISH WALNUT POLLEN 
english walnut pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0605
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS REGIA POLLEN (JUGLANS REGIA POLLEN) JUGLANS REGIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0605-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0605-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0605-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0605-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0605-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK WILLOW 
black willow injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0610
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) SALIX NIGRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
SODIUM BICARBONATE 0.0024 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0610-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0610-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0610-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0610-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0610-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PUSSY WILLOW 
pussy willow injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0609
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALIX DISCOLOR POLLEN (SALIX DISCOLOR POLLEN) SALIX DISCOLOR POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
SODIUM BICARBONATE 0.0024 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0609-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0609-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0609-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0609-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0609-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 09/09/1977
TREE OF HEAVEN 
tree of heaven injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0574
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AILANTHUS ALTISSIMA POLLEN (AILANTHUS ALTISSIMA POLLEN) AILANTHUS ALTISSIMA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0574-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0574-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0574-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0574-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0574-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LODGEPOLE PINE 
lodgepole pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0420
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS CONTORTA POLLEN (PINUS CONTORTA POLLEN) PINUS CONTORTA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0420-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0420-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0420-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0420-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0420-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CALIFORNIA BLACK WALNUT 
california black walnut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0603
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS CALIFORNICA POLLEN (JUGLANS CALIFORNICA POLLEN) JUGLANS CALIFORNICA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0603-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0603-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0603-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0603-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0603-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK WALNUT 
black walnut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0600
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0600-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0600-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0600-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0600-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0600-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASH MIXTURE 
ash mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0017
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS PENNSYLVANICA POLLEN (FRAXINUS PENNSYLVANICA POLLEN) FRAXINUS PENNSYLVANICA POLLEN 0.025 g  in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0017-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0017-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0017-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0017-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0017-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MULBERRY MIXTURE 
mulberry mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0311
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROUSSONETIA PAPYRIFERA POLLEN (BROUSSONETIA PAPYRIFERA POLLEN) BROUSSONETIA PAPYRIFERA POLLEN 0.0167 g  in 1 mL
MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) MORUS RUBRA POLLEN 0.0167 g  in 1 mL
MORUS ALBA POLLEN (MORUS ALBA POLLEN) MORUS ALBA POLLEN 0.0167 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0311-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0311-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0311-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0311-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0311-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HICKORY/PECAN MIXTURE 
hickory/pecan mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0266
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.025 g  in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0266-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0266-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0266-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0266-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0266-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 07/12/1996
HICKORY POLLEN MIXTURE 
hickory pollen mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0262
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA CORDIFORMIS POLLEN (CARYA CORDIFORMIS POLLEN) CARYA CORDIFORMIS POLLEN 0.0125 g  in 1 mL
CARYA GLABRA POLLEN (CARYA GLABRA POLLEN) CARYA GLABRA POLLEN 0.0125 g  in 1 mL
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.0125 g  in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.0125 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0262-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0262-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0262-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0262-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0262-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
OAK MIXTURE 
oak mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0331
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VELUTINA POLLEN (QUERCUS VELUTINA POLLEN) QUERCUS VELUTINA POLLEN 0.0063 g  in 1 mL
QUERCUS MACROCARPA POLLEN (QUERCUS MACROCARPA POLLEN) QUERCUS MACROCARPA POLLEN 0.0063 g  in 1 mL
QUERCUS MUEHLENBERGII POLLEN (QUERCUS MUEHLENBERGII POLLEN) QUERCUS MUEHLENBERGII POLLEN 0.0063 g  in 1 mL
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 0.0063 g  in 1 mL
QUERCUS RUBRA POLLEN (QUERCUS RUBRA POLLEN) QUERCUS RUBRA POLLEN 0.0063 g  in 1 mL
QUERCUS PALUSTRIS POLLEN (QUERCUS PALUSTRIS POLLEN) QUERCUS PALUSTRIS POLLEN 0.0063 g  in 1 mL
QUERCUS STELLATA POLLEN (QUERCUS STELLATA POLLEN) QUERCUS STELLATA POLLEN 0.0063 g  in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.0063 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORATE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0331-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0331-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0331-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0331-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0331-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MAPLE POLLEN MIXTURE 
maple pollen mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0308
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.0167 g  in 1 mL
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 0.0167 g  in 1 mL
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.0167 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0308-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0308-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0308-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0308-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0308-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BIRCH MIXTURE 
birch mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0056
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (BETULA LENTA POLLEN) BETULA LENTA POLLEN 0.0083 g  in 1 mL
BETULA PAPYRIFERA POLLEN (BETULA PAPYRIFERA POLLEN) BETULA PAPYRIFERA POLLEN 0.0083 g  in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.0083 g  in 1 mL
BETULA OCCIDENTALIS POLLEN (BETULA OCCIDENTALIS POLLEN) BETULA OCCIDENTALIS POLLEN 0.0083 g  in 1 mL
BETULA POPULIFOLIA POLLEN (BETULA POPULIFOLIA POLLEN) BETULA POPULIFOLIA POLLEN 0.0083 g  in 1 mL
BETULA ALLEGHANIENSIS POLLEN (BETULA ALLEGHANIENSIS POLLEN) BETULA ALLEGHANIENSIS POLLEN 0.0083 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0056-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0056-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0056-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0056-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0056-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TAMARACK 
tamarack injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0573
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LARIX OCCIDENTALIS POLLEN (LARIX OCCIDENTALIS POLLEN) LARIX OCCIDENTALIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0573-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0573-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0573-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0573-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0573-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ELM MIXTURE 
elm mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0184
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.025 g  in 1 mL
ULMUS PUMILA POLLEN (ULMUS PUMILA POLLEN) ULMUS PUMILA POLLEN 0.025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0184-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0184-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0184-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0184-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0184-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LOMBARDY POPLAR 
lombardy poplar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0419
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS NIGRA POLLEN (POPULUS NIGRA POLLEN) POPULUS NIGRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0419-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0419-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0419-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0419-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0419-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SCOTCH PINE 
scotch pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0421
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS SYLVESTRIS POLLEN (PINUS SYLVESTRIS POLLEN) PINUS SYLVESTRIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
SODIUM CHLORIDE 0.0095 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0421-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0421-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0421-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0421-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0421-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AUSTRALIAN PINE 
australian pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0412
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (CASUARINA EQUISETIFOLIA POLLEN) CASUARINA EQUISETIFOLIA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
SODIUM BICARBONATE 0.0024 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0412-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0412-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0412-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0412-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0412-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
RED PINE 
red pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0644
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS RESINOSA POLLEN (PINUS RESINOSA POLLEN) PINUS RESINOSA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0644-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0644-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0644-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0644-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0644-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE POPLAR 
white poplar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0418
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0418-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0418-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0418-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0418-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0418-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SLASH PINE 
slash pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0415
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ELLIOTTII POLLEN (PINUS ELLIOTTII POLLEN) PINUS ELLIOTTII POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0415-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0415-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0415-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0415-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0415-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
JAPANESE BLACK PINE 
japanese black pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0646
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS THUNBERGII POLLEN (PINUS THUNBERGII POLLEN) PINUS THUNBERGII POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0646-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0646-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0646-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0646-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0646-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AMERICAN SYCAMORE 
american sycamore injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0485
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0485-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0485-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0485-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0485-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0485-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
BLUE SPRUCE 
blue spruce injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0652
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PICEA PUNGENS POLLEN (PICEA PUNGENS POLLEN) PICEA PUNGENS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0652-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0652-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0652-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0652-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0652-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MAPLE LEAF SYCAMORE 
maple leaf sycamore injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0488
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS HYBRIDA POLLEN (PLATANUS HYBRIDA POLLEN) PLATANUS HYBRIDA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0488-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0488-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0488-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0488-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0488-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CALIFORNIA SYCAMORE 
california sycamore injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0487
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS RACEMOSA POLLEN (PLATANUS RACEMOSA POLLEN) PLATANUS RACEMOSA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0487-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0487-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0487-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0487-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0487-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PITCH PINE 
pitch pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0423
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS RIGIDA POLLEN (PINUS RIGIDA POLLEN) PINUS RIGIDA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0423-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0423-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0423-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0423-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0423-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LOBLOLLY PINE 
loblolly pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0422
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS TAEDA POLLEN (PINUS TAEDA POLLEN) PINUS TAEDA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0422-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0422-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0422-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0422-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0422-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SHORTLEAF PINE 
shortleaf pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0424
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS ECHINATA POLLEN (PINUS ECHINATA POLLEN) PINUS ECHINATA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0424-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0424-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0424-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0424-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0424-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
POPLAR MIXTURE 
poplar mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0397
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS NIGRA POLLEN (POPULUS NIGRA POLLEN) POPULUS NIGRA POLLEN 0.025 g  in 1 mL
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 0.025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0397-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0397-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0397-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0397-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0397-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EASTERN WHITE PINE 
eastern white pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0411
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (PINUS STROBUS POLLEN) PINUS STROBUS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0411-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0411-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0411-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0411-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0411-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 09/09/1979
NUMBER THREE OAK MIXTURE 
number three oak mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0357
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 0.0167 g  in 1 mL
QUERCUS RUBRA POLLEN (QUERCUS RUBRA POLLEN) QUERCUS RUBRA POLLEN 0.0167 g  in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.0167 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0357-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0357-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0357-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0357-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0357-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 07/12/1976
AUSTRIAN PINE 
austrian pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0645
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS NIGRA POLLEN (PINUS NIGRA POLLEN) PINUS NIGRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0645-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0645-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0645-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0645-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0645-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PECAN POLLEN 
pecan pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0392
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0392-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0392-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0392-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0392-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0392-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AUSTRALIAN PINE 
australian pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0413
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASUARINA EQUISETIFOLIA POLLEN (CASUARINA EQUISETIFOLIA POLLEN) CASUARINA EQUISETIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM CHLORIDE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0413-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0413-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0413-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0413-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0413-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PRIVET 
privet injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0399
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (LIGUSTRUM VULGARE POLLEN) LIGUSTRUM VULGARE POLLEN 0.02 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0399-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0399-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0399-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0399-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0399-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PECAN POLLEN 
pecan pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0393
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.02 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0393-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0393-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0393-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0393-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0393-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WASHINGTON/OREGON INLAND TREE MIXTURE 
washington/oregon inland tree mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0589
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (POPULUS TREMULOIDES POLLEN) POPULUS TREMULOIDES POLLEN 0.0056 g  in 1 mL
POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN (POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN) POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 0.0056 g  in 1 mL
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.0056 g  in 1 mL
PINUS CONTORTA POLLEN (PINUS CONTORTA POLLEN) PINUS CONTORTA POLLEN 0.0056 g  in 1 mL
FRAXINUS LATIFOLIA POLLEN (FRAXINUS LATIFOLIA POLLEN) FRAXINUS LATIFOLIA POLLEN 0.0056 g  in 1 mL
ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 0.0056 g  in 1 mL
BETULA OCCIDENTALIS POLLEN (BETULA OCCIDENTALIS POLLEN) BETULA OCCIDENTALIS POLLEN 0.0056 g  in 1 mL
PINUS PONDEROSA POLLEN (PINUS PONDEROSA POLLEN) PINUS PONDEROSA POLLEN 0.0056 g  in 1 mL
SALIX LUCIDA SSP. LASIANDRA POLLEN (SALIX LUCIDA SSP. LASIANDRA POLLEN) SALIX LUCIDA SSP. LASIANDRA POLLEN 0.0056 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0589-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0589-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0589-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0589-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0589-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 07/12/1996
AMERICAN SYCAMORE 
american sycamore injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0486
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0486-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0486-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0486-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0486-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0486-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE OAK 
white oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0351
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.050 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0351-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0351-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0351-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0351-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0351-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MAPLE POLLEN MIXTURE 
maple pollen mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0309
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.0067 g  in 1 mL
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 0.0067 g  in 1 mL
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.0067 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0309-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0309-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0309-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0309-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0309-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ELM MIXTURE 
elm mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0185
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.01 g  in 1 mL
ULMUS PUMILA POLLEN (ULMUS PUMILA POLLEN) ULMUS PUMILA POLLEN 0.01 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0185-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0185-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0185-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0185-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0185-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TREE MIXTURE 
tree mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0561
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (FAGUS GRANDIFOLIA POLLEN) FAGUS GRANDIFOLIA POLLEN 0.0008 g  in 1 mL
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 0.0008 g  in 1 mL
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.0008 g  in 1 mL
SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) SALIX NIGRA POLLEN 0.0008 g  in 1 mL
CARPINUS CAROLINIANA POLLEN (CARPINUS CAROLINIANA POLLEN) CARPINUS CAROLINIANA POLLEN 0.0008 g  in 1 mL
PICEA PUNGENS POLLEN (PICEA PUNGENS POLLEN) PICEA PUNGENS POLLEN 0.0008 g  in 1 mL
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.0008 g  in 1 mL
PINUS STROBUS POLLEN (PINUS STROBUS POLLEN) PINUS STROBUS POLLEN 0.0008 g  in 1 mL
CELTIS OCCIDENTALIS POLLEN (CELTIS OCCIDENTALIS POLLEN) CELTIS OCCIDENTALIS POLLEN 0.0008 g  in 1 mL
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.0008 g  in 1 mL
JUNIPERUS ASHEI POLLEN (JUNIPERUS ASHEI POLLEN) JUNIPERUS ASHEI POLLEN 0.0008 g  in 1 mL
BETULA PAPYRIFERA POLLEN (BETULA PAPYRIFERA POLLEN) BETULA PAPYRIFERA POLLEN 0.0008 g  in 1 mL
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 0.0008 g  in 1 mL
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 0.0008 g  in 1 mL
MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) MORUS RUBRA POLLEN 0.0008 g  in 1 mL
JUNIPERUS PINCHOTII POLLEN (JUNIPERUS PINCHOTII POLLEN) JUNIPERUS PINCHOTII POLLEN 0.0008 g  in 1 mL
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.0008 g  in 1 mL
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.0008 g  in 1 mL
LIQUIDAMBAR STYRACIFLUA POLLEN (LIQUIDAMBAR STYRACIFLUA POLLEN) LIQUIDAMBAR STYRACIFLUA POLLEN 0.0008 g  in 1 mL
AILANTHUS ALTISSIMA POLLEN (AILANTHUS ALTISSIMA POLLEN) AILANTHUS ALTISSIMA POLLEN 0.0008 g  in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.0008 g  in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.0008 g  in 1 mL
MORUS ALBA POLLEN (MORUS ALBA POLLEN) MORUS ALBA POLLEN 0.0008 g  in 1 mL
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 0.0008 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0561-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0561-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0561-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0561-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0561-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
OAK MIXTURE 
oak mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0332
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VELUTINA POLLEN (QUERCUS VELUTINA POLLEN) QUERCUS VELUTINA POLLEN 0.0025 g  in 1 mL
QUERCUS MACROCARPA POLLEN (QUERCUS MACROCARPA POLLEN) QUERCUS MACROCARPA POLLEN 0.0025 g  in 1 mL
QUERCUS MUEHLENBERGII POLLEN (QUERCUS MUEHLENBERGII POLLEN) QUERCUS MUEHLENBERGII POLLEN 0.0025 g  in 1 mL
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 0.0025 g  in 1 mL
QUERCUS RUBRA POLLEN (QUERCUS RUBRA POLLEN) QUERCUS RUBRA POLLEN 0.0025 g  in 1 mL
QUERCUS PALUSTRIS POLLEN (QUERCUS PALUSTRIS POLLEN) QUERCUS PALUSTRIS POLLEN 0.0025 g  in 1 mL
QUERCUS STELLATA POLLEN (QUERCUS STELLATA POLLEN) QUERCUS STELLATA POLLEN 0.0025 g  in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.0025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORATE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0332-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0332-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0332-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0332-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0332-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK WALNUT 
black walnut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0602
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.02 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0602-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0602-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0602-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0602-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0602-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK WALNUT 
black walnut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0601
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0601-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0601-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0601-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0601-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0601-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BIRCH MIXTURE 
birch mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0057
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (BETULA LENTA POLLEN) BETULA LENTA POLLEN 0.0033 g  in 1 mL
BETULA PAPYRIFERA POLLEN (BETULA PAPYRIFERA POLLEN) BETULA PAPYRIFERA POLLEN 0.0033 g  in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.0033 g  in 1 mL
BETULA OCCIDENTALIS POLLEN (BETULA OCCIDENTALIS POLLEN) BETULA OCCIDENTALIS POLLEN 0.0033 g  in 1 mL
BETULA POPULIFOLIA POLLEN (BETULA POPULIFOLIA POLLEN) BETULA POPULIFOLIA POLLEN 0.0033 g  in 1 mL
BETULA ALLEGHANIENSIS POLLEN (BETULA ALLEGHANIENSIS POLLEN) BETULA ALLEGHANIENSIS POLLEN 0.0033 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0057-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0057-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0057-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0057-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0057-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASH MIXTURE 
ash mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0018
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS PENNSYLVANICA POLLEN (FRAXINUS PENNSYLVANICA POLLEN) FRAXINUS PENNSYLVANICA POLLEN 0.01 g  in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.01 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0018-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0018-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0018-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0018-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0018-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LIVE OAK 
live oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0349
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0349-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0349-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0349-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0349-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0349-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WASHINGTON/OREGON COASTAL TREE MIXTURE 
washington/oregon coastal tree mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0588
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN (POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN) POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 0.0056 g  in 1 mL
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.0056 g  in 1 mL
PINUS CONTORTA POLLEN (PINUS CONTORTA POLLEN) PINUS CONTORTA POLLEN 0.0056 g  in 1 mL
JUGLANS REGIA POLLEN (JUGLANS REGIA POLLEN) JUGLANS REGIA POLLEN 0.0056 g  in 1 mL
QUERCUS GARRYANA POLLEN (QUERCUS GARRYANA POLLEN) QUERCUS GARRYANA POLLEN 0.0056 g  in 1 mL
FRAXINUS LATIFOLIA POLLEN (FRAXINUS LATIFOLIA POLLEN) FRAXINUS LATIFOLIA POLLEN 0.0056 g  in 1 mL
ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 0.0056 g  in 1 mL
BETULA OCCIDENTALIS POLLEN (BETULA OCCIDENTALIS POLLEN) BETULA OCCIDENTALIS POLLEN 0.0056 g  in 1 mL
SALIX LUCIDA SSP. LASIANDRA POLLEN (SALIX LUCIDA SSP. LASIANDRA POLLEN) SALIX LUCIDA SSP. LASIANDRA POLLEN 0.0056 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.535 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0588-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0588-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0588-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0588-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0588-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 07/12/1996
WHITE ASH 
white ash injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0022
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0022-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0022-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0022-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0022-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0022-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NUMBER SEVEN TREE MIXTURE 
number seven tree mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0590
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.0071 g  in 1 mL
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 0.0071 g  in 1 mL
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.0024 g  in 1 mL
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 0.0024 g  in 1 mL
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.0024 g  in 1 mL
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.0071 g  in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.0071 g  in 1 mL
JUNIPERUS VIRGINIANA (JUNIPERUS VIRGINIANA) JUNIPERUS VIRGINIANA 0.0071 g  in 1 mL
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 0.0071 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0590-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0590-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0590-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0590-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0590-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/02/1996
NUMBER TWO PINE MIXTURE 
number two pine mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0427
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS CONTORTA POLLEN (PINUS CONTORTA POLLEN) PINUS CONTORTA POLLEN 0.025 g  in 1 mL
PINUS PONDEROSA POLLEN (PINUS PONDEROSA POLLEN) PINUS PONDEROSA POLLEN 0.025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0427-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0427-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0427-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0427-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0427-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 12/02/1996
NUMBER THREE PINE MIXTURE 
number three pine mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0402
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS TAEDA POLLEN (PINUS TAEDA POLLEN) PINUS TAEDA POLLEN 0.0167 g  in 1 mL
PINUS PONDEROSA POLLEN (PINUS PONDEROSA POLLEN) PINUS PONDEROSA POLLEN 0.0167 g  in 1 mL
PINUS ECHINATA POLLEN (PINUS ECHINATA POLLEN) PINUS ECHINATA POLLEN 0.0167 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0402-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0402-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0402-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0402-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0402-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NUMBER ELEVEN TREE MIXTURE 
number eleven tree mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0584
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (FAGUS GRANDIFOLIA POLLEN) FAGUS GRANDIFOLIA POLLEN 0.0045 g  in 1 mL
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.0045 g  in 1 mL
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 0.0045 g  in 1 mL
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.0045 g  in 1 mL
SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) SALIX NIGRA POLLEN 0.0045 g  in 1 mL
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.0045 g  in 1 mL
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.0045 g  in 1 mL
QUERCUS RUBRA POLLEN (QUERCUS RUBRA POLLEN) QUERCUS RUBRA POLLEN 0.0045 g  in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.0045 g  in 1 mL
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.0045 g  in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.0045 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0584-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0584-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0584-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0584-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0584-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TREE MIXTURE 
tree mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0560
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (FAGUS GRANDIFOLIA POLLEN) FAGUS GRANDIFOLIA POLLEN 0.0021 g  in 1 mL
PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) PLATANUS OCCIDENTALIS POLLEN 0.0021 g  in 1 mL
JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) JUGLANS NIGRA POLLEN 0.0021 g  in 1 mL
SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) SALIX NIGRA POLLEN 0.0021 g  in 1 mL
CARPINUS CAROLINIANA POLLEN (CARPINUS CAROLINIANA POLLEN) CARPINUS CAROLINIANA POLLEN 0.0021 g  in 1 mL
PICEA PUNGENS POLLEN (PICEA PUNGENS POLLEN) PICEA PUNGENS POLLEN 0.0021 g  in 1 mL
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.0021 g  in 1 mL
PINUS STROBUS POLLEN (PINUS STROBUS POLLEN) PINUS STROBUS POLLEN 0.0021 g  in 1 mL
CELTIS OCCIDENTALIS POLLEN (CELTIS OCCIDENTALIS POLLEN) CELTIS OCCIDENTALIS POLLEN 0.0021 g  in 1 mL
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.0021 g  in 1 mL
JUNIPERUS ASHEI POLLEN (JUNIPERUS ASHEI POLLEN) JUNIPERUS ASHEI POLLEN 0.0021 g  in 1 mL
BETULA PAPYRIFERA POLLEN (BETULA PAPYRIFERA POLLEN) BETULA PAPYRIFERA POLLEN 0.0021 g  in 1 mL
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 0.0021 g  in 1 mL
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 0.0021 g  in 1 mL
MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) MORUS RUBRA POLLEN 0.0021 g  in 1 mL
JUNIPERUS PINCHOTII POLLEN (JUNIPERUS PINCHOTII POLLEN) JUNIPERUS PINCHOTII POLLEN 0.0021 g  in 1 mL
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.0021 g  in 1 mL
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.0021 g  in 1 mL
LIQUIDAMBAR STYRACIFLUA POLLEN (LIQUIDAMBAR STYRACIFLUA POLLEN) LIQUIDAMBAR STYRACIFLUA POLLEN 0.0021 g  in 1 mL
AILANTHUS ALTISSIMA POLLEN (AILANTHUS ALTISSIMA POLLEN) AILANTHUS ALTISSIMA POLLEN 0.0021 g  in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.0021 g  in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.0021 g  in 1 mL
MORUS ALBA POLLEN (MORUS ALBA POLLEN) MORUS ALBA POLLEN 0.0021 g  in 1 mL
POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) POPULUS ALBA POLLEN 0.0021 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0560-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0560-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0560-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0560-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0560-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BOX ELDER 
box elder injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0060
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0060-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0060-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0060-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0060-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0060-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MOUNTAIN CEDAR 
mountain cedar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0130
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (JUNIPERUS ASHEI POLLEN) JUNIPERUS ASHEI POLLEN 0.02 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0130-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0130-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0130-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0130-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0130-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MOUNTAIN CEDAR 
mountain cedar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0129
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (JUNIPERUS ASHEI POLLEN) JUNIPERUS ASHEI POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0129-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0129-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0129-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0129-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0129-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE HICKORY 
white hickory injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0265
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0265-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0265-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0265-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0265-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0265-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AMERICAN ELM 
american elm injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0191
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0191-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0191-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0191-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0191-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0191-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RED (RIVER) BIRCH 
red (river) birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0078
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0078-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0078-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0078-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0078-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0078-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EASTERN COTTONWOOD 
eastern cottonwood injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0084
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.02 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0084-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0084-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0084-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0084-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0084-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EASTERN COTTONWOOD 
eastern cottonwood injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0083
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0083-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0083-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0083-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0083-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0083-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EASTERN WHITE PINE 
eastern white pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0410
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS STROBUS POLLEN (PINUS STROBUS POLLEN) PINUS STROBUS POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0410-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0410-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0410-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0410-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0410-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
SALT CEDAR 
salt cedar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0133
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMARIX GALLICA POLLEN (TAMARIX GALLICA POLLEN) TAMARIX GALLICA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0133-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0133-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0133-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0133-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0133-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RED CEDAR 
red cedar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0132
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0132-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0132-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0132-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0132-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0132-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WESTERN COTTONWOOD 
western cottonwood injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0135
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0135-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0135-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0135-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0135-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0135-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK COTTONWOOD 
black cottonwood injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0134
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN (POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN) POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0134-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0134-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0134-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0134-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0134-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EASTERN COTTONWOOD 
eastern cottonwood injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0082
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0082-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0082-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0082-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0082-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0082-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
YELLOW BIRCH 
yellow birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0627
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA ALLEGHANIENSIS POLLEN (BETULA ALLEGHANIENSIS POLLEN) BETULA ALLEGHANIENSIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0627-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0627-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0627-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0627-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0627-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
REDBERRY JUNIPER 
redberry juniper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0131
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS PINCHOTII POLLEN (JUNIPERUS PINCHOTII POLLEN) JUNIPERUS PINCHOTII POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0131-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0131-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0131-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0131-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0131-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MOUNTAIN CEDAR 
mountain cedar injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0128
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS ASHEI POLLEN (JUNIPERUS ASHEI POLLEN) JUNIPERUS ASHEI POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0128-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0128-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0128-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0128-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0128-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ARIZONA CYPRESS 
arizona cypress injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0136
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUPRESSUS ARIZONICA POLLEN (CUPRESSUS ARIZONICA POLLEN) CUPRESSUS ARIZONICA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0136-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0136-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0136-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0136-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0136-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SWEET GUM 
sweet gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0226
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (LIQUIDAMBAR STYRACIFLUA POLLEN) LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0226-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0226-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0226-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0226-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0226-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CEDAR ELM 
cedar elm injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0195
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS CRASSIFOLIA POLLEN (ULMUS CRASSIFOLIA POLLEN) ULMUS CRASSIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0195-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0195-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0195-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0195-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0195-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HAZELNUT POLLEN 
hazelnut pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0261
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYLUS AMERICANA POLLEN (CORYLUS AMERICANA POLLEN) CORYLUS AMERICANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0261-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0261-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0261-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0261-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0261-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HACKBERRY 
hackberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0260
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELTIS OCCIDENTALIS POLLEN (CELTIS OCCIDENTALIS POLLEN) CELTIS OCCIDENTALIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0260-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0260-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0260-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0260-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0260-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AMERICAN ELM 
american elm injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0190
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0190-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0190-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0190-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0190-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0190-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
BALD CYPRESS 
bald cypress injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0144
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAXODIUM DISTICHUM POLLEN (TAXODIUM DISTICHUM POLLEN) TAXODIUM DISTICHUM POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0144-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0144-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0144-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0144-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0144-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EUCALYPTUS 
eucalyptus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0193
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTUS GLOBULUS POLLEN (EUCALYPTUS GLOBULUS POLLEN) EUCALYPTUS GLOBULUS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 g  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0193-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0193-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0193-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0193-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0193-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CHINESE (SIBERIAN) ELM 
chinese (siberian) elm injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0192
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ULMUS PUMILA POLLEN (ULMUS PUMILA POLLEN) ULMUS PUMILA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0192-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0192-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0192-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0192-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0192-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE ASH 
white ash injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0021
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0021-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0021-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0021-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0021-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0021-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
OREGON ASH 
oregon ash injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0020
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS LATIFOLIA POLLEN (FRAXINUS LATIFOLIA POLLEN) FRAXINUS LATIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0020-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0020-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0020-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0020-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0020-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/23/1974
GREEN ASH 
green ash injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0623
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS PENNSYLVANICA POLLEN (FRAXINUS PENNSYLVANICA POLLEN) FRAXINUS PENNSYLVANICA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0623-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0623-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0623-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0623-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0623-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASPEN POLLEN 
aspen pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0023
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POPULUS TREMULOIDES POLLEN (POPULUS TREMULOIDES POLLEN) POPULUS TREMULOIDES POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0023-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0023-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0023-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0023-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0023-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SMOOTH (TAG) ALDER 
smooth (tag) alder injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0015
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS INCANA SUBSP. RUGOSA POLLEN (ALNUS INCANA SUBSP. RUGOSA POLLEN) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
SODIUM BICARBONATE 0.0024 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0015-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0015-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0015-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0015-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0015-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/23/1974
ACACIA POLLEN 
acacia pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0014
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA BAILEYANA POLLEN (ACACIA BAILEYANA POLLEN) ACACIA BAILEYANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0014-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0014-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0014-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0014-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0014-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/23/1974
ARIZONA ASH 
arizona ash injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0019
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FRAXINUS VELUTINA POLLEN (FRAXINUS VELUTINA POLLEN) FRAXINUS VELUTINA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0019-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0019-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0019-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0019-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0019-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE ALDER 
white alder injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0016
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALNUS RHOMBIFOLIA POLLEN (ALNUS RHOMBIFOLIA POLLEN) ALNUS RHOMBIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0016-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0016-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0016-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0016-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0016-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLUE BEECH (HORNBEAM) 
blue beech (hornbeam) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0625
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARPINUS CAROLINIANA POLLEN (CARPINUS CAROLINIANA POLLEN) CARPINUS CAROLINIANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0625-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0625-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0625-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0625-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0625-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RED (RIVER) BIRCH 
red (river) birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0077
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0077-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0077-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0077-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0077-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0077-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
GROUNDSEL TREE 
groundsel tree injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0076
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACCHARIS HALIMIFOLIA POLLEN (BACCHARIS HALIMIFOLIA POLLEN) BACCHARIS HALIMIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0076-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0076-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0076-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0076-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0076-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK BIRCH 
black birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0626
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA LENTA POLLEN (BETULA LENTA POLLEN) BETULA LENTA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0626-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0626-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0626-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0626-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0626-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE BIRCH 
white birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0080
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA POPULIFOLIA POLLEN (BETULA POPULIFOLIA POLLEN) BETULA POPULIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0080-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0080-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0080-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0080-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0080-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BOX ELDER 
box elder injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0059
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0059-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0059-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0059-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0059-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0059-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
SPRING (WATER) BIRCH 
spring (water) birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0058
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA OCCIDENTALIS POLLEN (BETULA OCCIDENTALIS POLLEN) BETULA OCCIDENTALIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0058-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0058-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0058-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0058-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0058-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AMERICAN BEECH 
american beech injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0073
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAGUS GRANDIFOLIA POLLEN (FAGUS GRANDIFOLIA POLLEN) FAGUS GRANDIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0073-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0073-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0073-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0073-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0073-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PAPERBARK BIRCH 
paperbark birch injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0072
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETULA PAPYRIFERA POLLEN (BETULA PAPYRIFERA POLLEN) BETULA PAPYRIFERA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0072-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0072-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0072-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0072-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0072-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 08/09/1977
WHITE HICKORY 
white hickory injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0264
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0264-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0264-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0264-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0264-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0264-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
SHAGBARK HICKORY 
shagbark hickory injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0263
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA OVATA POLLEN (CARYA OVATA POLLEN) CARYA OVATA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0263-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0263-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0263-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0263-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0263-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CHESTNUT OAK 
chestnut oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0641
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS MUEHLENBERGII POLLEN (QUERCUS MUEHLENBERGII POLLEN) QUERCUS MUEHLENBERGII POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0641-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0641-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0641-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0641-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0641-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BUR OAK 
bur oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0352
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS MACROCARPA POLLEN (QUERCUS MACROCARPA POLLEN) QUERCUS MACROCARPA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0352-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0352-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0352-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0352-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0352-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PIN OAK 
pin oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0353
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS PALUSTRIS POLLEN (QUERCUS PALUSTRIS POLLEN) QUERCUS PALUSTRIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0353-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0353-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0353-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0353-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0353-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
POST OAK 
post oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0642
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS STELLATA POLLEN (QUERCUS STELLATA POLLEN) QUERCUS STELLATA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0642-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0642-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0642-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0642-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0642-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LIVE OAK 
live oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0348
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) QUERCUS VIRGINIANA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0348-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0348-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0348-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0348-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0348-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ORANGE POLLEN 
orange pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0347
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITRUS SINENSIS POLLEN (CITRUS SINENSIS POLLEN) CITRUS SINENSIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0347-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0347-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0347-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0347-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0347-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK OAK 
black oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0640
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS VELUTINA POLLEN (QUERCUS VELUTINA POLLEN) QUERCUS VELUTINA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0640-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0640-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0640-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0640-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0640-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE OAK 
white oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0350
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0350-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0350-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0350-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0350-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0350-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
RUSSIAN OLIVE 
russian olive injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0354
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELAEAGNUS ANGUSTIFOLIA POLLEN (ELAEAGNUS ANGUSTIFOLIA POLLEN) ELAEAGNUS ANGUSTIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0354-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0354-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0354-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0354-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0354-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PEPPER TREE 
pepper tree injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0400
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCHINUS MOLLE POLLEN (SCHINUS MOLLE POLLEN) SCHINUS MOLLE POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
SODIUM BICARBONATE 0.0024 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0400-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0400-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0400-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0400-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0400-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PRIVET 
privet injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0398
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIGUSTRUM VULGARE POLLEN (LIGUSTRUM VULGARE POLLEN) LIGUSTRUM VULGARE POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0398-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0398-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0398-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0398-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0398-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
QUEEN PALM 
queen palm injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0401
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SYAGRUS ROMANZOFFIANA POLLEN (SYAGRUS ROMANZOFFIANA POLLEN) SYAGRUS ROMANZOFFIANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0401-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0401-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0401-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0401-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0401-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GAMBEL OAK 
gambel oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0356
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS GAMBELII POLLEN (QUERCUS GAMBELII POLLEN) QUERCUS GAMBELII POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0356-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0356-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0356-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0356-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0356-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GARRYS OAK 
garrys oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0355
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS GARRYANA POLLEN (QUERCUS GARRYANA POLLEN) QUERCUS GARRYANA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
SODIUM BICARBONATE 0.0024 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0355-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0355-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0355-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0355-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0355-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PONDEROSA PINE 
ponderosa pine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0396
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINUS PONDEROSA POLLEN (PINUS PONDEROSA POLLEN) PINUS PONDEROSA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0396-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0396-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0396-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0396-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0396-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PECAN POLLEN 
pecan pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0391
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0391-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0391-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0391-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0391-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0391-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
COASTAL MAPLE 
coastal maple injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0307
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER MACROPHYLLUM POLLEN (ACER MACROPHYLLUM POLLEN) ACER MACROPHYLLUM POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0307-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0307-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0307-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0307-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0307-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WESTERN (SIERRA) JUNIPER 
western (sierra) juniper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0281
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS OCCIDENTALIS POLLEN (JUNIPERUS OCCIDENTALIS POLLEN) JUNIPERUS OCCIDENTALIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0281-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0281-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0281-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0281-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0281-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PAPER MULBERRY 
paper mulberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0636
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROUSSONETIA PAPYRIFERA POLLEN (BROUSSONETIA PAPYRIFERA POLLEN) BROUSSONETIA PAPYRIFERA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0636-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0636-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0636-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0636-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0636-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MESQUITE 
mesquite injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0310
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROSOPIS JULIFLORA POLLEN (PROSOPIS JULIFLORA POLLEN) PROSOPIS JULIFLORA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0310-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0310-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0310-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0310-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0310-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BITTERNUT HICKORY 
bitternut hickory injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0634
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA CORDIFORMIS POLLEN (CARYA CORDIFORMIS POLLEN) CARYA CORDIFORMIS POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0634-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0634-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0634-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0634-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0634-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PIGNUT HICKORY 
pignut hickory injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0633
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARYA GLABRA POLLEN (CARYA GLABRA POLLEN) CARYA GLABRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0633-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0633-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0633-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0633-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0633-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
UTAH JUNIPER 
utah juniper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0274
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS OSTEOSPERMA POLLEN (JUNIPERUS OSTEOSPERMA POLLEN) JUNIPERUS OSTEOSPERMA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0274-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0274-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0274-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0274-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0274-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ONESEED JUNIPER 
oneseed juniper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0273
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JUNIPERUS MONOSPERMA POLLEN (JUNIPERUS MONOSPERMA POLLEN) JUNIPERUS MONOSPERMA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0273-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0273-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0273-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0273-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0273-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MELALEUCA 
melaleuca injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0317
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELALEUCA QUINQUENERVIA POLLEN (MELALEUCA QUINQUENERVIA POLLEN) MELALEUCA QUINQUENERVIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0317-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0317-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0317-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0317-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0317-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CALIFORNIA (COASTAL) LIVE OAK 
california (coastal) live oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0337
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS AGRIFOLIA POLLEN (QUERCUS AGRIFOLIA POLLEN) QUERCUS AGRIFOLIA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
SODIUM CHLORIDE 0.0095 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0337-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0337-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0337-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0337-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0337-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE MULBERRY 
white mulberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0325
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS ALBA POLLEN (MORUS ALBA POLLEN) MORUS ALBA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
SODIUM CHLORIDE 0.0095 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0325-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0325-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0325-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0325-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0325-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
OLIVE POLLEN 
olive pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0339
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) OLEA EUROPAEA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0339-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0339-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0339-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0339-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0339-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NORTHERN RED OAK 
northern red oak injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0338
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUERCUS RUBRA POLLEN (QUERCUS RUBRA POLLEN) QUERCUS RUBRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
SODIUM CHLORIDE 0.0095 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0338-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0338-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0338-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0338-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0338-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient BLA102223 03/23/1974
RED MAPLE 
red maple injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0322
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER RUBRUM POLLEN (ACER RUBRUM POLLEN) ACER RUBRUM POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0322-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0322-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0322-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0322-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0322-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HARD (SUGAR) MAPLE 
hard (sugar) maple injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0321
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) ACER SACCHARUM POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0321-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0321-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0321-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0321-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0321-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RED MULBERRY 
red mulberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0324
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) MORUS RUBRA POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0324-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0324-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0324-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0324-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0324-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SOFT (SILVER) MAPLE 
soft (silver) maple injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0323
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACER SACCHARINUM POLLEN (ACER SACCHARINUM POLLEN) ACER SACCHARINUM POLLEN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0323-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0323-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0323-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0323-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0323-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
Labeler - Antigen Laboratories, Inc. (030705628)
Registrant - Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture
Revised: 11/2009
 
Antigen Laboratories, Inc.
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