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
- Preferred Pharmaceuticals, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 67679801-a8fe-4038-be71-96e1312badab
- SPL ID
- 73d293e2-385d-4dd7-a9de-fd112e8aa778
- Version
- 8
- Effective date
- 2026-04-16
- Source export date
- 2026-10-27
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/29a1aba6a935d72bab5474118c2ccf25cb52dfe8488fe1593c734ea6c04e3722/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 19:45:13
| 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 | 204097 | derived:openfda.application_number |
| application number | ANDA204097 | openfda.application_number | |
| brand name | Fexofenadine HCL | openfda.brand_name | |
| generic name | FEXOFENADINE HCL | openfda.generic_name | |
| manufacturer name | Preferred Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 68788-7449-1 | openfda.package_ndc |
| ndc | package | 68788-7449-9 | openfda.package_ndc |
| ndc | package | 68788-7449-3 | openfda.package_ndc |
| ndc | package | 68788-7449-6 | openfda.package_ndc |
| ndc | product | 68788-7449 | openfda.product_ndc |
| ndc11 | package | 68788744909 | derived:openfda.package_ndc |
| ndc11 | package | 68788744903 | derived:openfda.package_ndc |
| ndc11 | package | 68788744906 | derived:openfda.package_ndc |
| ndc11 | package | 68788744901 | derived:openfda.package_ndc |
| rxcui | 997420 | openfda.rxcui | |
| spl id | 73d293e2-385d-4dd7-a9de-fd112e8aa778 | id | |
| spl set id | 67679801-a8fe-4038-be71-96e1312badab | 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.