warnings
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
- Rising Pharma Holdings, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 5481ccb3-b311-4b25-b923-4fe8522ea92b
- SPL ID
- 538948d8-34aa-4460-8d66-ee8fcf4c60ab
- Version
- 13
- Effective date
- 2025-11-05
- Source export date
- 2026-09-28
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:39:34
| 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 | 077829 | derived:openfda.application_number |
| application number | ANDA077829 | openfda.application_number | |
| brand name | Cetirizine Hydrochloride | openfda.brand_name | |
| generic name | CETIRIZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Rising Pharma Holdings, Inc. | openfda.manufacturer_name | |
| ndc | package | 16571-402-10 | openfda.package_ndc |
| ndc | package | 16571-402-50 | openfda.package_ndc |
| ndc | package | 16571-402-30 | openfda.package_ndc |
| ndc | product | 16571-402 | openfda.product_ndc |
| ndc11 | package | 16571040230 | derived:openfda.package_ndc |
| ndc11 | package | 16571040210 | derived:openfda.package_ndc |
| ndc11 | package | 16571040250 | derived:openfda.package_ndc |
| rxcui | 1014678 | openfda.rxcui | |
| spl id | 538948d8-34aa-4460-8d66-ee8fcf4c60ab | id | |
| spl set id | 5481ccb3-b311-4b25-b923-4fe8522ea92b | 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.