"83057-0002-2" National Drug Code (NDC)

NDC Code	83057-0002-2
Package Description	1 BOTTLE in 1 CARTON (83057-0002-2) / 60 mL in 1 BOTTLE
Product NDC	83057-0002
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Novalgina Pediatrico Cough And Cold
Proprietary Name Suffix	Pediatrico
Non-Proprietary Name	Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form	LIQUID
Usage	ORAL
Start Marketing Date	20230201
Marketing Category Name	OTC MONOGRAPH FINAL
Application Number	part341
Manufacturer	HBC Pharma LLC
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Strength	7.5; 88; 2.5
Strength Unit	mg/mL; mg/mL; mg/mL
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]