ROBITUSSIN Nighttime Cough DM Soft CHEWS
- Product NDC
- 0031-9311
- 11-digit product format
- 000319311
- Labeler code
- 0031
- Product ID
- 0031-9311_4472847f-6aad-ca49-e063-6394a90a7ff3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, doxylamine succinate
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-06-19
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 15; 6.25 mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Nighttime Cough DM Soft CHEWS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 2685210 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0031-9311-20 | ROBITUSSIN Nighttime Cough DM Soft CHEWS | 20 in 1 BOTTLE | TABLET, CHEWABLE | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0031-9311 | ROBITUSSIN NIGHTTIME COUGH DM SOFT CHEWS (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC] | 1 | Current NDC, 1 package rows | 20240619_39468746-e06d-4849-9d06-9af4d14351b0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0031-9311-20 | 00031931120 | 20 TABLET, CHEWABLE in 1 BOTTLE (0031-9311-20) | 2024-06-19 | No | No | Historical |