"50580-402-72" National Drug Code (NDC)

NDC Code	50580-402-72
Package Description	3 CARTON in 1 PACKAGE (50580-402-72) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC	50580-402
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Tylenol Cold Plus Flu
Proprietary Name Suffix	Severe
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20110901
Marketing Category Name	OTC MONOGRAPH DRUG
Application Number	M012
Manufacturer	Kenvue Brands LLC
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Strength	325; 10; 200; 5
Strength Unit	mg/1; mg/1; mg/1; mg/1
Pharmacy Classes	Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]