warnings
Warnings
Fexofenadine Hydrochloride and Pseudoephedrine 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 and Pseudoephedrine Hydrochloride
- Generic name
- FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1
- SPL ID
- 554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8
- Version
- 13
- Effective date
- 2025-03-11
- Source export date
- 2026-10-27
- 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/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:47:58
| 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 | 090818 | derived:openfda.application_number |
| application number | ANDA090818 | openfda.application_number | |
| brand name | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | openfda.brand_name | |
| generic name | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 47335-724-94 | openfda.package_ndc |
| ndc | package | 47335-724-83 | openfda.package_ndc |
| ndc | package | 47335-724-64 | openfda.package_ndc |
| ndc | package | 47335-724-75 | openfda.package_ndc |
| ndc | package | 47335-724-66 | openfda.package_ndc |
| ndc | package | 47335-724-60 | openfda.package_ndc |
| ndc | package | 47335-724-99 | openfda.package_ndc |
| ndc | package | 47335-724-95 | openfda.package_ndc |
| ndc | product | 47335-724 | openfda.product_ndc |
| ndc11 | package | 47335072464 | derived:openfda.package_ndc |
| ndc11 | package | 47335072466 | derived:openfda.package_ndc |
| ndc11 | package | 47335072460 | derived:openfda.package_ndc |
| ndc11 | package | 47335072499 | derived:openfda.package_ndc |
| ndc11 | package | 47335072495 | derived:openfda.package_ndc |
| ndc11 | package | 47335072483 | derived:openfda.package_ndc |
| ndc11 | package | 47335072475 | derived:openfda.package_ndc |
| ndc11 | package | 47335072494 | derived:openfda.package_ndc |
| rxcui | 997406 | openfda.rxcui | |
| spl id | 554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8 | id | |
| spl set id | 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1 | set_id | |
| unii | 2S068B75ZU | openfda.unii | |
| unii | 6V9V2RYJ8N | 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.