| NDC Code | 55315-443-12 |
| Package Description | 355 mL in 1 BOTTLE, PLASTIC (55315-443-12) |
| Product NDC | 55315-443 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Cold And Flu Relief |
| Proprietary Name Suffix | Nighttime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate |
| Dosage Form | LIQUID |
| Usage | ORAL |
| Start Marketing Date | 20180331 |
| End Marketing Date | 20240630 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | Freds Inc |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Strength | 650; 30; 12.5 |
| Strength Unit | mg/30mL; mg/30mL; mg/30mL |
| 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] |