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
- Pioneer Life Sciences, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5
- SPL ID
- 3fd79863-077e-4c9c-958d-91f709c6d033
- Version
- 3
- Effective date
- 2025-06-01
- Source export date
- 2026-11-06
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/3744b3ae389d13e8f30cade845ea29e0fc75bb043dcda980c2025693f0c10522/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 09:06:28
| 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 | Pioneer Life Sciences, LLC | openfda.manufacturer_name | |
| ndc | package | 72090-010-99 | openfda.package_ndc |
| ndc | product | 72090-010 | openfda.product_ndc |
| ndc11 | package | 72090001099 | derived:openfda.package_ndc |
| rxcui | 997420 | openfda.rxcui | |
| spl id | 3fd79863-077e-4c9c-958d-91f709c6d033 | id | |
| spl set id | d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5 | 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.