"55758-507-01" National Drug Code (NDC)

NDC Code	55758-507-01
Package Description	1 BLISTER PACK in 1 CARTON (55758-507-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product NDC	55758-507
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Niaflu
Non-Proprietary Name	Dextromethorphan Hbr, Guaifenesin
Dosage Form	CAPSULE, LIQUID FILLED
Usage	ORAL
Start Marketing Date	20250710
Marketing Category Name	OTC MONOGRAPH DRUG
Application Number	M012
Manufacturer	Pharmadel LLC
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Strength	20; 400
Strength Unit	mg/1; mg/1
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]