warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Cetirizine 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
- Cetirizine Hydrochloride
- Generic name
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- Granules USA, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- c8d711cd-7214-c7d5-e053-2995a90a6b67
- SPL ID
- 468e40c3-a669-29bd-e063-6394a90a8812
- Version
- 5
- Effective date
- 2025-12-22
- Source export date
- 2026-10-27
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:58:39
| Harmonized routes |
|---|
| ORAL |
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 | 209274 | derived:openfda.application_number |
| application number | ANDA209274 | openfda.application_number | |
| brand name | Cetirizine Hydrochloride | openfda.brand_name | |
| generic name | CETIRIZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Granules USA, Inc. | openfda.manufacturer_name | |
| ndc | package | 69848-006-09 | openfda.package_ndc |
| ndc | product | 69848-006 | openfda.product_ndc |
| ndc11 | package | 69848000609 | derived:openfda.package_ndc |
| rxcui | 1014678 | openfda.rxcui | |
| spl id | 468e40c3-a669-29bd-e063-6394a90a8812 | id | |
| spl set id | c8d711cd-7214-c7d5-e053-2995a90a6b67 | set_id | |
| unii | 64O047KTOA | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.