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] |