NDC 65131-180

BRONCOCHEM MAXIMUM COUGH KIDS

Dextromethorphan Hbr-guaifenesin

BRONCOCHEM MAXIMUM COUGH KIDS is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Laboratorio Magnachem International Srl. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID65131-180_a0bd3860-b58b-4e71-846c-354c603d1500
NDC65131-180
Product TypeHuman Otc Drug
Proprietary NameBRONCOCHEM MAXIMUM COUGH KIDS
Generic NameDextromethorphan Hbr-guaifenesin
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2017-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLABORATORIO MAGNACHEM INTERNATIONAL SRL
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength10 mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65131-180-98

1 BOTTLE, PLASTIC in 1 BOX (65131-180-98) > 120 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2017-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65131-180-98 [65131018098]

BRONCOCHEM MAXIMUM COUGH KIDS SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL

OpenFDA Data

SPL SET ID:b0fd2f2f-5cc4-4813-8f99-c78fbe898656
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298228
  • UPC Code
  • 0805418098409

  • Trademark Results [BRONCOCHEM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BRONCOCHEM
    BRONCOCHEM
    85365505 4102132 Live/Registered
    Global Corporation
    2011-07-07
    BRONCOCHEM
    BRONCOCHEM
    75813839 2405940 Dead/Cancelled
    GLOBAL CORPORATION
    1999-10-04

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.