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
- ce7402d1-e48f-4bf1-90e9-cc57a52b35e5
- SPL ID
- df1662fe-6e62-4093-a047-654e3b700ab3
- Version
- 13
- Effective date
- 2024-06-27
- Source export date
- 2026-10-12
- 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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:40:34
| 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 | 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 | 65162-700-77 | openfda.package_ndc |
| ndc | package | 65162-700-76 | openfda.package_ndc |
| ndc | product | 65162-700 | openfda.product_ndc |
| ndc11 | package | 65162070077 | derived:openfda.package_ndc |
| ndc11 | package | 65162070076 | derived:openfda.package_ndc |
| rxcui | 1373045 | openfda.rxcui | |
| spl id | df1662fe-6e62-4093-a047-654e3b700ab3 | id | |
| spl set id | ce7402d1-e48f-4bf1-90e9-cc57a52b35e5 | 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.