Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
- Product NDC
- 0031-8765
- 11-digit product format
- 000318765
- Labeler code
- 0031
- Product ID
- 0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9ef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- ANDA207602
- Marketing category
- ANDA
- Marketing start
- 2019-06-14
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 60; 1200 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Maximum Strength 12 Hour Cough and Mucus Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 60 mg/1 |
| GUAIFENESIN | 1200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1099074 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0031-8765-04 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 4 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 4 | | 5 |
| 0031-8765-04 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 0031-8765-08 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 8 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 8 | | 5 |
| 0031-8765-08 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 0031-8765-16 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 5 |
| 0031-8765-16 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief | 8 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 8 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0031-8765 | ROBITUSSIN MAXIMUM STRENGTH 12 HOUR COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240410_96409b52-b0ec-444b-bc39-fd41070e9855.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 |
|---|
| 0031-8765-04 | 00031876504 | 1 BLISTER PACK in 1 CARTON (0031-8765-04) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2019-06-14 | 0000-00-00 | No | No | Current |
| 0031-8765-08 | 00031876508 | 1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2019-06-14 | 0000-00-00 | No | No | Current |
| 0031-8765-16 | 00031876516 | 2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2019-06-14 | 0000-00-00 | No | No | Current |