"27854-350-01" National Drug Code (NDC)

NDC Code	27854-350-01
Package Description	2 BLISTER PACK in 1 CARTON (27854-350-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC	27854-350
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Sedalmex Xl Flu
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20220324
Marketing Category Name	OTC MONOGRAPH DRUG
Application Number	M012
Manufacturer	Belmora LLC
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Strength	325; 10; 100; 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]