| NDC Code | 80587-183-01 |
|---|
| Package Description | 20 mL in 1 BOTTLE (80587-183-01) |
|---|
| Product NDC | 80587-183 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Duratuss |
|---|
| Proprietary Name Suffix | Dm |
|---|
| Non-Proprietary Name | Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide And Pseudoephedrine Hydrochloride |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20250925 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | Prime Labs LLC dba Quality CDMO |
|---|
| Substance Name | DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 1; 10; 30 |
|---|
| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC] |
|---|