warnings
Warnings
Pseudoephedrine 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
- Pseudoephedrine HCl
- Generic name
- PSEUDOEPHEDRINE HCL
- Manufacturer
- Aurohealth LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 1056d9da-8a3f-4b7a-878e-7f8d45d298cd
- SPL ID
- 5f73d533-1e3b-4e36-8bea-6076b9d0a9b5
- Version
- 3
- Effective date
- 2022-11-03
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:09:34
| 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 | 209008 | derived:openfda.application_number |
| application number | ANDA209008 | openfda.application_number | |
| brand name | Pseudoephedrine HCl | openfda.brand_name | |
| generic name | PSEUDOEPHEDRINE HCL | openfda.generic_name | |
| manufacturer name | Aurohealth LLC | openfda.manufacturer_name | |
| ndc | package | 58602-804-67 | openfda.package_ndc |
| ndc | package | 58602-804-83 | openfda.package_ndc |
| ndc | product | 58602-804 | openfda.product_ndc |
| ndc11 | package | 58602080467 | derived:openfda.package_ndc |
| ndc11 | package | 58602080483 | derived:openfda.package_ndc |
| rxcui | 1049154 | openfda.rxcui | |
| spl id | 5f73d533-1e3b-4e36-8bea-6076b9d0a9b5 | id | |
| spl set id | 1056d9da-8a3f-4b7a-878e-7f8d45d298cd | set_id | |
| 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.