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Positive Skin Test Control - Histamine 6 mg/mL Injection, 5 mL — NDC 65044-9998-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Positive Skin Test Control - Histamine 6 mg/mL Injection, 5 mL — NDC 65044-9998-1 (Billing 65044-9998-01)

by Jubilant HollisterStier LLC · 5 mL in 1 VIAL

This is a package of 5 mL of Positive Skin Test Control - Histamine 6 mg/mL Injection from Jubilant HollisterStier LLC, marketed since Jun 1995 and currently FDA-listed. It is this product's only package size.

NDC 65044-9998-01
🏷️ FDA NDC (as labeled) 65044-9998-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 65044-9998-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65044 labeler · 9998 product · 1 package
Package marketed since
Jun 15, 1995
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
5 mL per package
Barcode (UPC-A, from the NDC)
3 6504499981 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65044-9998-1
Product NDC 65044-9998
11-digit billing NDC 65044999801
NCPDP billing unit ML — per mL (volume)
UNII 820484N8I3
Application # BLA103891
SPL Set ID 5c20f3f4-65f8-4cdb-bdd1-5774da1c551b
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1995-06-15
Route PERCUTANEOUS
Dosage form INJECTION
Substance HISTAMINE
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 94200050052030
GPI class Positive Skin Test Control
GCN Seq No 071751
GCN 35714
HICL code 013420
Ingredient (HICL) Histamine Dihydrochloride
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z9
Therapeutic class — intermediate (HIC2) Unclassified Drugs
HIC3 code Z9D
Therapeutic class — specific (HIC3) Diagnostic Preparations,Miscellaneous
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name POSITIVE SKIN TEST CTRL-HISTMN
FDB brand name Positive Skin Test Ctrl-Histmn
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071751
  • GCN: 35714
  • GPI-14 (Medi-Span): 94200050052030
  • HICL (First Databank): 013420
  • AHFS class code: 36:00.00.00
Why two NDCs? The FDA registers this code as 65044-9998-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 65044-9998-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name POSITIVE SKIN TEST CTRL-HISTMN Ingredient Histamine Dihydrochloride

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65044-9998-01 You're viewing this Main listing 5 mL in 1 VIAL 1995-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Positive Skin Test Control - Histamine 6 mg/mLthis 65044-9998-01 Jubilant 5 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2024
First FDA approval
Mar 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2036. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 13, 2024 ⏳ ~9.4 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2024 2026 2028 2030 2032 2034 2036
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMar 13, 2036
Common questions
Is there a biosimilar for POSITIVE SKIN TEST CTRL-HISTMN?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJubilant HollisterStier LLC
FDA applicationBLA103891 (BLA)
Labeler code65044
First marketedJun 1995
Product typeHuman Prescription Drug
Portfolio370 products on file

More NDCs from Jubilant HollisterStier LLC labeler code 65044

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 35 words ▾

POSITIVE SKIN TEST CONTROL - HISTAMINE For Percutaneous (Scratch, Prick or Puncture) Administration Histamine Base: 6mg/mL (Histamine Dihydrochloride: 10mg/mL) This product is to be used by a physician or under the supervision of a physician.

🎯 Indications and Usage 39 words ▾

INDICATIONS AND USAGE Positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION (1) General Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prior to testing, clean the skin area with ether or alcohol and allow to dry. The back or the volar surface of the arms are the most satisfactory sites for testing.

Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret there. The most satisfactory areas of the back 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 of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space. The histamine test should be applied in the same test area as other allergenic extracts tests, but spaced no closer than 4 to 5 cm from adjacent test sites. Use the same technique or procedure that you use for allergen testing.

The negative control is the diluent used in the extract to be tested (e.g. 50% glycerin, Sterile Albumin Saline with Phenol, Sterile Buffered Saline with Phenol). With each skin testing method, in order for the reaction to Positive Skin Test Control-Histamine (6 mg/mL Histamine Base) to be considered valid, erythema must be present which exceeds the respective negative control by 4 mm (∑E).

A wheal reaction does not have to be elicited unless there is a wheal reaction to the respective negative control. In this case, the wheal of the positive control must exceed the negative control by 4 mm (∑W) in order to be considered appropriate. Record measurement of erythema and wheal diameters.

Tables 1 and 2 summarize skin testing results with histamine base and controls in atopic and non-atopic subjects using four different devices and methods. (2) Scratch, Prick or Puncture Test: Positive Skin Test Control-Histamine, 6.0 mg/mL Histamine Base. The Scratch, Prick or Puncture test should be read in 15 minutes.

If a large wheal reaction occurs before that time, wipe excess histamine solution from test site. a) Use a sterile scarifier for each patient. Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt the outer layers of epidermis down to the germinal layer, but should not produce immediate oozing of blood.

The amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin. Apply one drop of Positive Skin Test Control-Histamine to the scratch test site. b) Prick or Puncture Test: Prick tests are performed by placing a drop of extract on the skin and piercing through the drop into the skin with a slight lifting motion. Puncture tests are performed by placing a drop of extract on the skin and piercing through the drop perpendicular to the skin with a device such as a Prick Lancetter.

After about 1 minute the extract may be wiped away with a dry sponge.

⛔ Contraindications 34 words ▾

CONTRAINDICATIONS Positive Skin Test Control - Histamine is contraindicated in patients with a history of hypersensitivity to histamine products, and in patients with hypotension, severe hypertension, vasomotor instability, severe cardiac, pulmonary or renal disease.

⚠️ Warnings 60 words ▾

WARNINGS Attacks of severe asthma or other serious allergic conditions may be precipitated by the administration of Histamine Dihydrochloride in patients with bronchial disease. Caution is advised in using histamine in such patients and in those with a history of bronchial asthma. Histamine Dihydrochloride has not been approved for unlabeled use as gastric acid stimulus or for detecting bronchial hyperactivity.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Large doses of histamine may precipitate systemic reactions. These reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypotension or hypertension, abdominal cramps, vomiting, metallic taste, local or generalized allergic manifestations. An antihistamine preparation may be given orally, I.M. or I.V. to prevent or ameliorate systemic reactions to the drug.

If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.

Epinephrine Dosage: ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary. PEDIATRIC: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg(mL) per square meter of body surface area.

Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient.

After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Oxygen should be given by mask. Aminophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given.

Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (Ref. J. ALLERGY AND CLINICAL IMMUNOLOGY 77s (2): p.

271-273, 1986). 16 Rarely are all of the above measures necessary, the tourniquet and epinephrine usually producing prompt responses. However, the physician should be prepared in advance for all contingencies.

Promptness in beginning emergency treatment measures is of utmost importance. Adverse Event Reporting Report all adverse events to Jubilant HollisterStier LLC Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program.

Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

🔄 Drug Interactions 129 words ▾

(2) Drug Interactions: Certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.

7 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 7,8 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing. 9 The physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing.

Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 10

🤰 Pregnancy 52 words ▾

(4) Pregnancy: Positive Skin Test Control-Histamine. Animal reproduction studies have not been conducted on Histamine Dihydrochloride. It is also not known whether Histamine Dihydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Histamine Dihydrochloride should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 43 words ▾

(6) Pediatric Use: Indications and dosage for the pediatric population are the same as for adults; however, the reactions to histamine are smaller. Studies have shown that the use of histamine solutions for skin test is safe in infants and young children. 4,5,6

🆘 Overdosage 45 words ▾

OVERDOSAGE Overdosage may cause severe symptoms, including circulatory collapse, shock, and even death. Intravenous administration of histamine in normal volunteers at doses of up to 1.0 µg/kg/min produced flushing, headaches, tachycardia and decreased diastolic blood pressure. 1,2,3 See ADVERSE REACTIONS Section for emergency treatment steps.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Pharmacological actions of histamine include the increase of capillary and post capillary venular permeability. This vascular change leads to the wheal-flare response. Large reactions can cause an amplification of a reaction to a nearby skin test.

Histamine is degraded either by oxidative deamination or by methylation and oxidative deamination so that the principal excretion products are imidazoleacetic acid-riboside and 1-methyl imidazoleacetic acid respectively. 2 10 atopic subjects and 10 non-atopics were tested with Positive Skin Test Control - Histamine Solutions, and two negative control solutions. Thirteen females (35-49 years old; mean age 36.5) and 7 males (23-45 years old; mean age 36.4) were tested.

This study included 19 Caucasian subjects and 1 African American subject. Different skin test devices produce different skin test responses. (14,15) Study results are summarized in Table 1 and Table 2.

Atopic and non-atopic subject information was combined, as there were no significant differences in their skin responses. Summation of wheal (∑W) or summation of erythema (∑E) was determined by measuring the longest diameter and the mid-point orthoganol diameter of the wheal or erythema response and summing the two measurements. Malling tested 25 subjects using a straight needle prick technique with Histamine Dihydrochloride 10mg/mL and found wheal single diameters of 5.4-8.5mm (mean 7 mm).

13 Histamine Dihydrochloride at 10mg/mL has been shown to elicit fewer false negative and false positive reactions than Histamine Dihydrochloride at 1mg/mL. 12 10mg/mL Histamine Dihydrochloride has been shown to be the appropriate strength to perform biological standardization using skin reactivity to histamine as a standard of comparison. 11,13 Histamine Table1 Histamine Table2

📦 How Supplied / Storage and Handling 23 words ▾

HOW SUPPLIED SCRATCH, PRICK or PUNCTURE TEST: Positive Skin Test Control-Histamine (6.0 mg/mL Histamine Base), 5 mL sterile amber vial with dropper assembly.

📦 Storage and Handling 12 words ▾

STORAGE Store at 2°- 8°C. Protect from light when not in use.

📋 Description 91 words ▾

DESCRIPTION Histamine Dihydrochloride contains histamine, a potent vasodilator having the chemical name 2-(4-Imidazolyl) ethylamine. Histamine has an empirical formula of C 5 H 9 N 3 , a molecular weight of 111.15, and the following chemical structure: Histamine Dihydrochloride is available in the following strengths: 1. SCRATCH, PRICK or PUNCTURE TEST CONTROL: Positive Skin Test Control - Histamine contains 6.0 mg/mL Histamine Base and is a clear, colorless, sterile solution.

It consists of Histamine Dihydrochloride 10mg/mL, Sodium Chloride 0.5%, Sodium Bicarbonate 0.275%, and Glycerin 50.0% (v/v) as a preservative. Histamine Chemical

⚠️ Precautions ~2 min read ▾

PRECAUTIONS (1) General: It is necessary that scarifiers, syringes, and needles be properly sterilized before use on each patient to prevent the possibility of accidental transfer of serum hepatitis and other infectious agents from one person to another. Disposable products may also be used. Always have injectable epinephrine and a tourniquet available when any skin tests are being made.

(See ADVERSE REACTIONS Section) Patients should be observed in the office for 30 minutes after administration of the test and instructed to return to the office promptly if symptoms of an allergic reaction or shock occur. (2) Drug Interactions: Certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing.

Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing. 7 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 7,8 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.

9 The physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing. Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 10 (3) Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed on Positive Skin Test Control-Histamine.

(4) Pregnancy: Positive Skin Test Control-Histamine. Animal reproduction studies have not been conducted on Histamine Dihydrochloride. It is also not known whether Histamine Dihydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Histamine Dihydrochloride should be given to a pregnant woman only if clearly needed. (5) Nursing Mothers: It is unknown whether Histamine Dihydrochloride affects lactation or is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Positive Skin Test Control-Histamine is administered to a nursing woman.

(6) Pediatric Use: Indications and dosage for the pediatric population are the same as for adults; however, the reactions to histamine are smaller. Studies have shown that the use of histamine solutions for skin test is safe in infants and young children. 4,5,6

🍼 Nursing Mothers 40 words ▾

(5) Nursing Mothers: It is unknown whether Histamine Dihydrochloride affects lactation or is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Positive Skin Test Control-Histamine is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 words ▾

(3) Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed on Positive Skin Test Control-Histamine.

📚 References ~2 min read ▾

REFERENCES 1. Lawlor, Glenn Jr., Thomas J. Fischer, ed., Immediate hypersensitivity: approach to diagnosis.

Manual of Allergy and Immunology Diagnosis and Therapy. Little Brown and Company, Boston, 19, 95, 1981. 2.

Samter, Max, K. Frank Austin, ed.. Histamine and other mediators of allergic reactions.

Immunological Diseases. Little, Brown and Company, Boston, pp. 332-335, 1971.

3. Summers, Richard, Robert Sigler, James H. Schelhamer, and Michael Kaliner.

Effects of infused histamine on asthmatic and normal subjects: comparison of skin test responses. J. Allergy Clin.

Immunol. 67 (6): 456-464, June 1981. 4.

Gary, T.N., L.N. Gay. Skin reactions in infants: Susceptibility of the skin of the newborn to positive atopic sensitization, comparison with reaction to histamine.

J. Allergy. 5:488, 1934.

5. Kaliner, M., J. H.

Shelhamer, and E.A. Ottesen. Effects of infused histamine: Correlation of plasma histamine levels and symptoms.

J. Allergy Clin. Immunol.

69 (3): 283-289. 6. Smith, M.A., L.E.

Mansfeld, R. deShazo and H.S. Nelson. An evaluation of the pharmacologic inhibition of the immediate and late cutaneous effect to allergen.

J. Allergy Clin. Immunol.

65: 188, 1980. 7. Pipkorn, Ulf.

Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.

8. Andersson, M. and U. Pipkorn.

Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clinical Immunology.

79(2): 345-349, February 1987. 9. Rao, Kamineni S., et al.

Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clinical Immunology.

82: 752-757, November 1988. 10. Pipkorn, Ulf, and M.

Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy.

17: 307-311, 1987. 11. Harris, R.I., M.A.

Stern, H.K. Watson. Dose response curve of allergen and histamine in skin prick tests.

Allergy. 43(8): 565-572, 1988. 12.

Berkowitz, R.B., D.G. Tinkleman, C. Lutz, et al.

Evaluation of the multi test device for immediate hypersensitivity skin testing. J. Allergy Clin.

Immunol. 90:979-985, 1992. 13.

Malling, H. J. Skin prick testing and the use of histamine references.

Allergy. 39:596-601, 1984. 14.

Demoly, P., J. Bousquet, J.C. Manderscheid, et al.

Precision of skin prick and puncture tests with nine methods. J. Allergy Clin.

Immunol. 88(5):758-762, Nov. 1991.

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📄 Package Label / Principal Display Panel 59 words ▾

PRINCIPAL DISPLAY PANEL 5mL Positive Skin Test Control-Histamine, Carton 7099ED – 5mL 10 mg/mL Positive Skin Test Control-Histamine, Carton Label 7099ED – 5mL 10 mg/mL Positive Skin Test Control-Histamine, Container Label 5mL Positive Skin Test Control-Histamine, Carton 7099ED – 5mL 10 mg/mL Positive Skin Test Control-Histamine, Carton Label 7099ED – 5mL 10 mg/mL Positive Skin Test Control-Histamine, Container Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Positive Skin Test Control - Histamine (this brand).

Top reported reactions

Pruritus18
Cough16
Headache15
Dyspnoea12
Rash12
Back Pain11
Fatigue11

Age at onset

Child1
Adolescent1
Adult12
Elderly2

Reporter sex

141 reports
Male · 26%
Female · 72%
Unknown · 2%

Serious outcomes

Hospitalization39
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Jubilant HollisterStier LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jubilant HollisterStier LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65044-9994-01 · Jubilant 65050-0058-03 · Wuxi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.