NDC 49523-505

Baczol Cold Medicine

Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate

Baczol Cold Medicine is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Lex Inc. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide; Chlorpheniramine Maleate.

Product ID49523-505_25259b06-cfdb-4497-8a12-a27a0a0f65dd
NDC49523-505
Product TypeHuman Otc Drug
Proprietary NameBaczol Cold Medicine
Generic NameAcetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-02-04
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLex Inc
Substance NameACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength250 mg/5mL; mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49523-505-04

1 BOTTLE in 1 CARTON (49523-505-04) > 120 mL in 1 BOTTLE
Marketing Start Date2013-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49523-505-04 [49523050504]

Baczol Cold Medicine LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-04
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN250 mg/5mL

OpenFDA Data

SPL SET ID:d46090ad-63c5-4161-a4ea-5bcd98ff25ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370440
  • NDC Crossover Matching brand name "Baczol Cold Medicine" or generic name "Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate"

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

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