"70518-3515-0" National Drug Code (NDC)

NDC Code	70518-3515-0
Package Description	1 BOTTLE in 1 CARTON (70518-3515-0) > 118 mL in 1 BOTTLE
Product NDC	70518-3515
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Leader Tussin Dm
Non-Proprietary Name	Dextromethorphan Hbr, Guaifenesin
Dosage Form	SOLUTION
Usage	ORAL
Start Marketing Date	20220912
Marketing Category Name	OTC MONOGRAPH FINAL
Application Number	part341
Manufacturer	REMEDYREPACK INC.
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Strength	20; 200
Strength Unit	mg/10mL; mg/10mL
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]