NDC 52083-623

Tusslin Pediatric

Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl

Tusslin Pediatric is a Oral Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID52083-623_21bcaf13-5dfa-40b4-b74b-169e27280fc3
NDC52083-623
Product TypeHuman Otc Drug
Proprietary NameTusslin Pediatric
Generic NameDextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl
Dosage FormSolution/ Drops
Route of AdministrationORAL
Marketing Start Date2014-01-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52083-623-01

30 mL in 1 BOTTLE, DROPPER (52083-623-01)
Marketing Start Date2014-01-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-623-01 [52083062301]

Tusslin Pediatric SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-01-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/mL

OpenFDA Data

SPL SET ID:6fe91407-08c1-465b-9c00-251c94b1f7f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1487369
  • NDC Crossover Matching brand name "Tusslin Pediatric" or generic name "Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    52083-641DesgenDextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
    52083-678G-TRONDextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
    52083-623TusslinDextromethorphan Hbr, Guiafenesin, Phenylephrine HCl

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