NDC 58552-133

Giltuss Childrens Cough and Chest Congestion

Dextromethorphan Hydrobromide, Guaifenesin

Giltuss Childrens 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 ID58552-133_852d5f01-928a-5515-e053-2a91aa0acf32
NDC58552-133
Product TypeHuman Otc Drug
Proprietary NameGiltuss Childrens Cough and Chest Congestion
Generic NameDextromethorphan Hydrobromide, Guaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-10-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength10 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-133-04

1 BOTTLE in 1 CARTON (58552-133-04) > 118 mL in 1 BOTTLE
Marketing Start Date2018-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58552-133-04 [58552013304]

Giltuss Childrens Cough and Chest Congestion SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-10-02

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:852d5f01-9289-5515-e053-2a91aa0acf32
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996520

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

    NDCBrand NameGeneric Name
    58552-133Giltuss Childrens Cough and Chest CongestionGiltuss Childrens 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
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