NDC 52083-639

G-TUSICOF

Dextromethorphan, Guaifenesin, And Phenylephrine

G-TUSICOF is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID52083-639_3e6452b2-a583-47e7-a0e8-cc70045a7383
NDC52083-639
Product TypeHuman Otc Drug
Proprietary NameG-TUSICOF
Generic NameDextromethorphan, Guaifenesin, And Phenylephrine
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2012-09-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength20 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-639-16

474 mL in 1 BOTTLE (52083-639-16)
Marketing Start Date2019-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-639-16 [52083063916]

G-TUSICOF SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL

OpenFDA Data

SPL SET ID:d169585f-b4f4-4831-8c71-e1533ae7e7c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091331
  • UPC Code
  • 0352083639166
  • NDC Crossover Matching brand name "G-TUSICOF" or generic name "Dextromethorphan, Guaifenesin, And Phenylephrine"

    NDCBrand NameGeneric Name
    52083-639G-TUSICOFdextromethorphan, guaifenesin, and phenylephrine
    52083-239TUSICOFdextromethorphan, guaifenesin, and phenylephrine

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