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
- 2026-10-12
- 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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:52:20
| 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.