NDC 43913-403

G-BRONCO-D

Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

G-BRONCO-D is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Mclaren Medical Inc. The primary component is Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID43913-403_509fb31b-09bb-4671-be8f-3dcf1771cbd3
NDC43913-403
Product TypeHuman Otc Drug
Proprietary NameG-BRONCO-D
Generic NameGuaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMCLAREN MEDICAL INC
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength200 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43913-403-16

474 mL in 1 BOTTLE (43913-403-16)
Marketing Start Date2012-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43913-403-16 [43913040316]

G-BRONCO-D SUSPENSION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/5mL

OpenFDA Data

SPL SET ID:632d4219-7c36-4ed1-a5d0-7d0021b778a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1486140
  • NDC Crossover Matching brand name "G-BRONCO-D" or generic name "Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    43913-403G-BRONCO-DGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    53809-250DOMETUSS-GGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    75834-040Nivanex DMXGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0904-6309Robafen CF Cough and coldGuaifenesin, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride

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