GUAIFENESIN AND DEXTROMETHORPHAN HBr
- Product NDC
- 48433-221
- 11-digit product format
- 484330221
- Labeler code
- 48433
- Product ID
- 48433-221_1d3c7180-99b1-4a08-929d-a4515d977c7a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- guaifenesin and dextromethorphan hydrobromide
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-02-01
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 48433-221-40 | 48433022140 | 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (48433-221-40) > 5 mL in 1 CUP, UNIT-DOSE (48433-221-05) | 2022-02-01 | 0000-00-00 | No | No | Current |