Histamine Positive Skin Test Control
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Histamine Positive Skin Test Control
- Generic name
- HISTAMINE PHOSPHATE
- Manufacturer
- ALK-Abello, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1159c24c-d9ce-49a2-b0bd-dc27c710f146
- SPL ID
- b405798b-4f02-4236-9b5d-00da85a2c6c4
- Version
- 4
- Effective date
- 2020-08-28
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:43
| Harmonized routes |
|---|
| PERCUTANEOUS, INTRADERMAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | BLA | 103754 | derived:openfda.application_number |
| application number | BLA103754 | openfda.application_number | |
| brand name | Histamine Positive Skin Test Control | openfda.brand_name | |
| generic name | HISTAMINE PHOSPHATE | openfda.generic_name | |
| manufacturer name | ALK-Abello, Inc. | openfda.manufacturer_name | |
| ndc | package | 0268-0248-05 | openfda.package_ndc |
| ndc | package | 0268-0247-05 | openfda.package_ndc |
| ndc | product | 0268-0247 | openfda.product_ndc |
| ndc | product | 0268-0248 | openfda.product_ndc |
| ndc11 | package | 00268024705 | derived:openfda.package_ndc |
| ndc11 | package | 00268024805 | derived:openfda.package_ndc |
| spl id | b405798b-4f02-4236-9b5d-00da85a2c6c4 | id | |
| spl set id | 1159c24c-d9ce-49a2-b0bd-dc27c710f146 | set_id | |
| unii | QWB37T4WZZ | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Care must be taken in intracutaneous testing to avoid injection into a venule or capillary. Pull back gently on the syringe plunger and note if blood is drawn. If blood is drawn, withdraw needle and inject into another skin site. Small doses by any route of administration may precipitate asthma in patients with bronchial hyperactivity. This product is not intended for inhalation, or subcutaneous injection. The utmost caution is advised in using histamine in such patients and in those with a history of bronchial asthma.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Local: Reactions such as wheal, erythema and localized pruritus are to be expected, but if very large (i.e. greater than 4+ as described dosage and administration) may be the first manifestation of a systemic reaction. Systemic: Following the injection of large doses of histamine, systemic reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypertension or hypotension, abdominal cramps, vomiting, metallic taste, and local or generalized allergic manifestations (see also OVERDOSAGE ).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.