warnings
Warnings
FEXOFENADINE 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
- FEXOFENADINE HYDROCHLORIDE
- Generic name
- FEXOFENADINE HYDROCHLORIDE
- Manufacturer
- NUVICARE LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- ec55732c-a3db-4445-a06d-0f98b21ed134
- SPL ID
- 5788217f-a09d-407f-a749-d7fed955ea1b
- Version
- 1
- Effective date
- 2025-06-09
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:04:49
| 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 | 210137 | derived:openfda.application_number |
| application number | ANDA210137 | openfda.application_number | |
| brand name | FEXOFENADINE HYDROCHLORIDE | openfda.brand_name | |
| generic name | FEXOFENADINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | NUVICARE LLC | openfda.manufacturer_name | |
| ndc | package | 84324-008-02 | openfda.package_ndc |
| ndc | product | 84324-008 | openfda.product_ndc |
| ndc11 | package | 84324000802 | derived:openfda.package_ndc |
| rxcui | 997420 | openfda.rxcui | |
| spl id | 5788217f-a09d-407f-a749-d7fed955ea1b | id | |
| spl set id | ec55732c-a3db-4445-a06d-0f98b21ed134 | set_id | |
| unii | 2S068B75ZU | 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.