NDC 58552-132

Giltuss HBP Cough and Chest Congestion

Dextromethorphan Hydrobromide, Guaifenesin

Giltuss HBP Cough and Chest Congestion is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID58552-132_852d984d-bb98-33bd-e053-2991aa0a1850
NDC58552-132
Product TypeHuman Otc Drug
Proprietary NameGiltuss HBP Cough and Chest Congestion
Generic NameDextromethorphan Hydrobromide, Guaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-11-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength20 mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-132-04

1 BOTTLE in 1 CARTON (58552-132-04) > 118 mL in 1 BOTTLE
Marketing Start Date2018-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58552-132-04 [58552013204]

Giltuss HBP Cough and Chest Congestion SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-11-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL

OpenFDA Data

SPL SET ID:852ceea2-d6a1-6de2-e053-2a91aa0ad50d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996520

    • NDC Crossover Matching brand name "Giltuss HBP Cough and Chest Congestion" or generic name "Dextromethorphan Hydrobromide, Guaifenesin"

    NDCBrand NameGeneric Name
    58552-132Giltuss HBP Cough and Chest CongestionGiltuss HBP Cough and Chest Congestion
    0363-1603adult tussin dmdextromethorphan hydrobromide, guaifenesin
    0280-0089Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizzdextromethorphan hydrobromide, guaifenesin
    0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, Guaifenesin
    0113-7419basic care mucus dmdextromethorphan hydrobromide, guaifenesin
    0536-1313Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7134Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7135Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8715Childrens Robitussin Cough and Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0363-0419CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-0419Good Sense Childrens Mucus Relief CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin
    0113-0359good sense tussin dmDextromethorphan Hydrobromide, Guaifenesin
    0113-1725good sense tussin dmdextromethorphan hydrobromide, guaifenesin
    0363-0505Mucus Relief DMdextromethorphan hydrobromide, guaifenesin
    0363-6812mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0904-7223robafen dmdextromethorphan hydrobromide, guaifenesin
    0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8739ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMdextromethorphan hydrobromide, guaifenesin
    0031-8759Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0536-1348rugby cough syrupdextromethorphan hydrobromide, guaifenesin
    0372-0050Scot-Tussin Senior SF DMEXPDextromethorphan Hydrobromide, Guaifenesin
    0067-8118TriaminicDextromethorphan Hydrobromide, Guaifenesin
    0363-1144tussin dm maxDextromethorphan Hydrobromide, Guaifenesin
    0904-5180Tussin Sugar Free CoughDextromethorphan Hydrobromide, GUAIFENESIN
    11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0363-0359Wal TussinDextromethorphan Hydrobromide, Guaifenesin
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.