12 HR RELIEF COUGH DM
- Product NDC
- 51316-263
- 11-digit product format
- 513160263
- Labeler code
- 51316
- Product ID
- 51316-263_fcfcff9e-c6b4-4d99-9c1e-e05349cf2eed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- ANDA091135
- Marketing category
- ANDA
- Marketing start
- 2026-04-14
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 30 mg/5mL
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 12 HR RELIEF COUGH DM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH |
| Rxcui | 1373045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-263-21 | 12 HR RELIEF COUGH DM | 1 in 1 CARTON | SUSPENSION | 1 | | 2 |
| 51316-263-21 | 12 HR RELIEF COUGH DM | 89 mL in 1 BOTTLE | SUSPENSION | 89 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-263-21 | 51316026321 | 1 BOTTLE in 1 CARTON (51316-263-21) / 89 mL in 1 BOTTLE | 1 bottle | 2026-04-14 | No | No | Historical |