HYDROXYZINE HYDROCHLORIDE
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
- HYDROXYZINE HYDROCHLORIDE
- Generic name
- HYDROXYZINE HYDROCHLORIDE
- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 16a63845-6619-293b-e063-6394a90a0a5c
- SPL ID
- 19869100-35c6-c014-e063-6294a90a4f11
- Version
- 2
- Effective date
- 2024-05-28
- Source export date
- 2026-09-28
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:06
| Harmonized routes |
|---|
| INTRAMUSCULAR |
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 | ANDA | 087408 | derived:openfda.application_number |
| application number | ANDA087408 | openfda.application_number | |
| brand name | HYDROXYZINE HYDROCHLORIDE | openfda.brand_name | |
| generic name | HYDROXYZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | HF Acquisition Co LLC, DBA HealthFirst | openfda.manufacturer_name | |
| ndc | package | 51662-1649-2 | openfda.package_ndc |
| ndc | package | 51662-1649-3 | openfda.package_ndc |
| ndc | product | 51662-1649 | openfda.product_ndc |
| ndc11 | package | 51662164903 | derived:openfda.package_ndc |
| ndc11 | package | 51662164902 | derived:openfda.package_ndc |
| rxcui | 995270 | openfda.rxcui | |
| spl id | 19869100-35c6-c014-e063-6294a90a4f11 | id | |
| spl set id | 16a63845-6619-293b-e063-6394a90a0a5c | set_id | |
| unii | 76755771U3 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Tissue damage: Intramuscular hydroxyzine hydrochloride may result in severe injection site reactions (including extensive tissue damage, necrosis and gangrene) requiring surgical intervention (including debridement, skin grafting and amputation).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Therapeutic doses of hydroxyzine seldom produce impairment of mental alertness. However, drowsiness may occur; if so, it is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses. Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered in the recommended doses for over four years of uninterrupted therapy. The absence of adverse effects has been further demonstrated in experimental studies in which excessively high doses were administered. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Continuous therapy with over one gram per day has been employed in some patients without these effects having been encountered. Hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) in post marketing reports.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.