Guaifenesin and Dextromethorphan Hydrobromide
- Product NDC
- 57631-013
- 11-digit product format
- 576310013
- Labeler code
- 57631
- Product ID
- 57631-013_402896d4-831f-c53d-e063-6294a90a21b3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Dextromethorphan Hydrobromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- InvaTech Pharma Solutions LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-13
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 400 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
- Guaifenesin and Dextromethorphan Hydrobromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1147685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57631-013-10 | Guaifenesin and Dextromethorphan Hydrobromide | 26500 in 1 BOX | TABLET | 26500 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57631-013-10 | 57631001310 | 26500 TABLET in 1 BOX (57631-013-10) | 26500 tablet | 2021-01-13 | No | No | Current |