| NDC Code | 57237-312-51 |
|---|
| Package Description | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05) |
|---|
| Product NDC | 57237-312 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Dextromethorphan Hbr. And Guaifenesin |
|---|
| Non-Proprietary Name | Dextromethorphan Hbr. And Guaifenesin |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20230612 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Rising Pharma Holdings, Inc. |
|---|
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
|---|
| Strength | 10; 100 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy 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] |
|---|