| NDC Code | 84324-019-01 |
| Package Description | 1 BLISTER PACK in 1 CARTON (84324-019-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Product NDC | 84324-019 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Nuvicare Nighttime Cold And Flu Softgel |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Usage | ORAL |
| Start Marketing Date | 20250520 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | NUVICARE LLC |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Strength | 325; 15; 6.25 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |