Quick answers
- What is Histamine used for?
- The FDA-approved label (Positive Skin Test Control - Histamine, Jubilant HollisterStier LLC, April 3, 2026) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Histamine have a boxed warning?
- Yes. The FDA label for Positive Skin Test Control - Histamine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Histamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Histamine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Histamine?
- 1 company lists prescription products of Histamine in the FDA NDC Directory, including Jubilant HollisterStier LLC.
What Histamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Positive Skin Test Control - Histamine, Jubilant HollisterStier LLC, effective April 3, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Percutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Positive Skin Test Control - Histamine |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Jubilant HollisterStier LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103891 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 5c20f3f4-65f8-4cdb-bdd1-5774da1c551b |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | BLA103891 |
| Active ingredients (FDA) | HISTAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Positive Skin Test Control - Histamine, Jubilant HollisterStier LLC, effective April 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →