"69365-001-01" National Drug Code (NDC)

NDC Code	69365-001-01
Package Description	1 BLISTER PACK in 1 KIT (69365-001-01) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product NDC	69365-001
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Facol Cold And Flu Day
Non-Proprietary Name	Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hydrobromide
Dosage Form	CAPSULE, LIQUID FILLED
Usage	ORAL
Start Marketing Date	20150801
Marketing Category Name	OTC MONOGRAPH DRUG
Application Number	M012
Manufacturer	JW Holdings
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Strength	200; 8; 35; 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]