"58809-216-08" National Drug Code (NDC)

NDC Code	58809-216-08
Package Description	237 mL in 1 BOTTLE (58809-216-08)
Product NDC	58809-216
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Texaclear Kids Daytime Cough And Chest Congestion
Non-Proprietary Name	Dextromethorphan Hbr, Guaifenesin
Dosage Form	LIQUID
Usage	ORAL
Start Marketing Date	20231025
Marketing Category Name	OTC MONOGRAPH DRUG
Application Number	M012
Manufacturer	GM Pharmaceuticals, INC
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Strength	5; 100
Strength Unit	mg/15mL; mg/15mL
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]