warnings
Warnings
Dextromethorphan Hydrobromide
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
- Dextromethorphan Hydrobromide
- Generic name
- DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- Softgel Healthcare Pvt Ltd
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 20f7c1a9-fc4d-1f51-e063-6394a90a8be3
- SPL ID
- 5003763c-806d-cd6b-e063-6294a90a374f
- Version
- 5
- Effective date
- 2026-04-27
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:26:11
| 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 number | M012 | openfda.application_number | |
| brand name | Dextromethorphan Hydrobromide | openfda.brand_name | |
| generic name | DEXTROMETHORPHAN HYDROBROMIDE | openfda.generic_name | |
| manufacturer name | Softgel Healthcare Pvt Ltd | openfda.manufacturer_name | |
| ndc | package | 35916-0461-1 | openfda.package_ndc |
| ndc | package | 35916-0461-4 | openfda.package_ndc |
| ndc | package | 35916-0461-2 | openfda.package_ndc |
| ndc | package | 35916-0461-3 | openfda.package_ndc |
| ndc | product | 35916-0461 | openfda.product_ndc |
| ndc11 | package | 35916046102 | derived:openfda.package_ndc |
| ndc11 | package | 35916046101 | derived:openfda.package_ndc |
| ndc11 | package | 35916046104 | derived:openfda.package_ndc |
| ndc11 | package | 35916046103 | derived:openfda.package_ndc |
| rxcui | 1090487 | openfda.rxcui | |
| spl id | 5003763c-806d-cd6b-e063-6294a90a374f | id | |
| spl set id | 20f7c1a9-fc4d-1f51-e063-6394a90a8be3 | set_id | |
| unii | 9D2RTI9KYH | 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.