"65852-015-01" National Drug Code (NDC)

Giltuss Bucalsep 1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC
(Dextrum Laboratories Inc.)

NDC Code65852-015-01
Package Description1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC
Product NDC65852-015
Product Type NameHUMAN OTC DRUG
Proprietary NameGiltuss Bucalsep
Non-Proprietary NameBenzocaine, Menthol, Zinc Chloride
Dosage FormSPRAY
UsageORAL; TOPICAL
Start Marketing Date20180726
Marketing Category NameOTC MONOGRAPH DRUG
Application NumberM022
ManufacturerDextrum Laboratories Inc.
Substance NameBENZOCAINE; MENTHOL; ZINC CATION
Strength6.5; .1; .12
Strength Unitmg/100mL; mg/100mL; mg/100mL
Pharmacy ClassesAllergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]

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