Prescription and over-the-counter medicine
Histamine
Histamine is a prescription and over-the-counter medicine with an FDA approval on record since 1939. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the histamine FDA label on DailyMed (effective November 3, 2025); the NDA 734 record on Drugs@FDA; every histamine label on DailyMed.
Highlights of the record
FDA label of November 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRelieves allergies *
Forms and strengths
- 0.275 mg/ml
- 2.75 mg/ml
- 6 mg/ml
Solution; injection; injection (solution).
On the market
- Earliest approval on file
- April 25, 1939 Histamine Phosphate, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included; 10 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 228 through July 30, 2026
What is histamine used for?
From the label: indications and usageRelieves allergies *
Source: FDA drug label (Histaminum hydrochloricum), Boiron, effective November 3, 2025 (SPL set 85b905d4-5fa3-7125-e053-2a91aa0a54f4), via openFDA; the full label on DailyMed
Is there a generic for histamine?
No generic histamine is approved (Drugs@FDA, October 8, 2026).
- 1939 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has histamine been recalled?
The FDA's Enforcement Report lists 3 recalls naming histamine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of histamine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
| September 6, 2013 | Class II | Triangle Compounding not a listed maker | Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the histamine label say about other medicines?
The histamine label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlorpheniramine | drug interactions (prescription label) | The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole). |
| Cromolyn | drug interactions (prescription label) | Short acting steroids, inhaled beta agonists, theophylline and cromolyn do not seem to affect skin test response. |
| Doxepin | drug interactions | Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing. |
| Ephedrine | drug interactions (prescription label) | Beta 2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal. |
| Propranolol | drug interactions (prescription label) | Beta Blocking Agents: Propranolol can significantly increase skin test reactivity, including histamine. |
| Terbutaline | drug interactions (prescription label) | Beta 2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal. |
| Theophylline | drug interactions (prescription label) | Short acting steroids, inhaled beta agonists, theophylline and cromolyn do not seem to affect skin test response. |
Source: FDA drug label (Histaminum hydrochloricum), Boiron, effective November 3, 2025 (SPL set 85b905d4-5fa3-7125-e053-2a91aa0a54f4), via openFDA; the full label on DailyMed
What do FAERS reports show for histamine?
The FDA Adverse Event Reporting System holds 228 reports that list histamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 44 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Histamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other