Robitussin 12 Hour Cough Relief
- Product NDC
- 0031-8754
- 11-digit product format
- 000318754
- Labeler code
- 0031
- Product ID
- 0031-8754_159a0a07-055f-e1e2-e063-6394a90a9a37
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- ANDA091135
- Marketing category
- ANDA
- Marketing start
- 2016-07-05
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Robitussin 12 Hour Cough Relief
- Listing expiration
- 2026-12-31
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 |
|---|
| 0031-8754-15 | Robitussin 12 Hour Cough Relief | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | | 7 |
| 0031-8754-15 | Robitussin 12 Hour Cough Relief | 148 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 148 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| POLISTIREX | INACTIVE INGREDIENT | 5H9W9GTW27 | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| SODIUM POLYSTYRENE SULFONATE | INACTIVE INGREDIENT | 1699G8679Z | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| TRAGACANTH | INACTIVE INGREDIENT | 2944357O2O | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0031-8754 | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240410_5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0031-8754-15 | 00031875415 | 1 BOTTLE in 1 CARTON (0031-8754-15) / 148 mL in 1 BOTTLE | 1 bottle | 2016-07-05 | 0000-00-00 | No | No | Current |