NDC 76864-208

BACZOL COLD MEDICINE

Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl

BACZOL COLD MEDICINE is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Laboratorios Lopez S.a. De C.v.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID76864-208_3b921621-7d54-49dc-9e2a-ed0853d71fd2
NDC76864-208
Product TypeHuman Otc Drug
Proprietary NameBACZOL COLD MEDICINE
Generic NameAcetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2020-05-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLaboratorios Lopez S.A. de C.V.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength250 mg/5mL; mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76864-208-01

1 BOTTLE, PLASTIC in 1 CARTON (76864-208-01) > 120 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2020-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76864-208-01 [76864020801]

BACZOL COLD MEDICINE SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-25

Drug Details

NDC Crossover Matching brand name "BACZOL COLD MEDICINE" or generic name "Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl"

NDCBrand NameGeneric Name
49523-505Baczol Cold MedicineACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE
76864-208BACZOL COLD MEDICINEACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl
76864-464Pulmo CalcioACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl

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