warnings
WARNINGS
Fexofenadine HCL
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 HCL
- Generic name
- FEXOFENADINE HCL
- Manufacturer
- Akron Pharma Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 08023b99-0634-4ac9-afd6-4f2d2e0d2c8a
- SPL ID
- 8ac3ac9a-206b-446a-87c9-bda3b8441cd4
- Version
- 4
- Effective date
- 2024-08-20
- Source export date
- 2026-09-28
- 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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:24:35
| 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 | 204507 | derived:openfda.application_number |
| application number | ANDA204507 | openfda.application_number | |
| brand name | Fexofenadine HCL | openfda.brand_name | |
| generic name | FEXOFENADINE HCL | openfda.generic_name | |
| manufacturer name | Akron Pharma Inc. | openfda.manufacturer_name | |
| ndc | package | 71399-8042-1 | openfda.package_ndc |
| ndc | package | 71399-8042-3 | openfda.package_ndc |
| ndc | product | 71399-8042 | openfda.product_ndc |
| ndc11 | package | 71399804203 | derived:openfda.package_ndc |
| ndc11 | package | 71399804201 | derived:openfda.package_ndc |
| rxcui | 997420 | openfda.rxcui | |
| spl id | 8ac3ac9a-206b-446a-87c9-bda3b8441cd4 | id | |
| spl set id | 08023b99-0634-4ac9-afd6-4f2d2e0d2c8a | 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.