warnings
WARNINGS Warnings
Dextromethorphan Polistirex Extended-Release
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 Polistirex Extended-Release
- Generic name
- DEXTROMETHORPHAN POLISTIREX
- Manufacturer
- Amneal Pharmaceuticals LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e0104a59-0bc2-4401-8c14-7f28499dbac6
- SPL ID
- 9eb36122-c3bf-4b04-84a1-bb137f884c40
- Version
- 10
- Effective date
- 2024-06-27
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:25:23
| 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 | 203133 | derived:openfda.application_number |
| application number | ANDA203133 | openfda.application_number | |
| brand name | Dextromethorphan Polistirex Extended-Release | openfda.brand_name | |
| generic name | DEXTROMETHORPHAN POLISTIREX | openfda.generic_name | |
| manufacturer name | Amneal Pharmaceuticals LLC | openfda.manufacturer_name | |
| ndc | package | 65162-799-76 | openfda.package_ndc |
| ndc | package | 65162-799-77 | openfda.package_ndc |
| ndc | product | 65162-799 | openfda.product_ndc |
| ndc11 | package | 65162079977 | derived:openfda.package_ndc |
| ndc11 | package | 65162079976 | derived:openfda.package_ndc |
| rxcui | 1373045 | openfda.rxcui | |
| spl id | 9eb36122-c3bf-4b04-84a1-bb137f884c40 | id | |
| spl set id | e0104a59-0bc2-4401-8c14-7f28499dbac6 | 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.