NDC 36800-794

TopCare Chest Congestion Relief

Guaifenesin

TopCare Chest Congestion Relief is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Guaifenesin.

Product ID36800-794_176e9443-0b0b-48c2-ab57-880d5404fbf1
NDC36800-794
Product TypeHuman Otc Drug
Proprietary NameTopCare Chest Congestion Relief
Generic NameGuaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTOPCO ASSOCIATES LLC
Substance NameGUAIFENESIN
Active Ingredient Strength400 mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-794-50

1 BOTTLE, PLASTIC in 1 CARTON (36800-794-50) > 50 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-794-50 [36800079450]

TopCare Chest Congestion Relief TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:b8339617-17ce-4ad7-af38-399ecc74d864
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359601
  • UPC Code
  • 0036800135888
  • NDC Crossover Matching brand name "TopCare Chest Congestion Relief" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    36800-794TopCare Chest Congestion ReliefTopCare Chest Congestion Relief
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

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