TOPCO
- Product NDC
- 76162-751
- 11-digit product format
- 761620751
- Labeler code
- 76162
- Product ID
- 76162-751_434f6496-b36a-c575-e063-6294a90ac9ba
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HBr AND GUAIFENESIN
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-10-21
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 5; 100 mg/5mL; mg/5mL
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9D2RTI9KYH | DEXTROMETHORPHAN HYDROBROMIDE | 6700-34-1 | DEXTROMETHORPHAN HYDROBROMIDE |
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-751-04 | 76162075104 | 1 BOTTLE in 1 CARTON (76162-751-04) / 118 mL in 1 BOTTLE | 1 bottle | 2024-10-21 | No | No | Historical |