NDC 42213-162

Ultra Tuss Safe

Guaifenesin Dextromethorphan Hbr

Ultra Tuss Safe is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Ultra Seal Corporation. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

Product ID42213-162_449decfe-316b-4cd2-a939-e8e04b8aaa25
NDC42213-162
Product TypeHuman Otc Drug
Proprietary NameUltra Tuss Safe
Generic NameGuaifenesin Dextromethorphan Hbr
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2012-06-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameUltra Seal Corporation
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength100 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42213-162-83

1 BOTTLE in 1 CARTON (42213-162-83) > 119 mL in 1 BOTTLE (42213-162-86)
Marketing Start Date2012-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42213-162-83 [42213016283]

Ultra Tuss Safe SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-19

NDC 42213-162-86 [42213016286]

Ultra Tuss Safe SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-19

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:b82c4e24-040e-461f-bb5a-9827d0461842
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996520
    • UPC Code
  • 0001500162861

    • NDC Crossover Matching brand name "Ultra Tuss Safe" or generic name "Guaifenesin Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    42213-162Ultra Tuss Safeguaifenesin dextromethorphan HBr
    42961-121First Aid Direct Cough Relief DMguaifenesin dextromethorphan HBr
    42213-161Ultra Tuss DMguaifenesin dextromethorphan HBr
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