NDC 53145-333

Defensol-ito

Dextromethorphan, Guiafenesin, Phenylephrine

Defensol-ito is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Menper Distributors, Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID53145-333_a1f00436-cce6-484c-a714-68e1113a800d
NDC53145-333
Product TypeHuman Otc Drug
Proprietary NameDefensol-ito
Generic NameDextromethorphan, Guiafenesin, Phenylephrine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMenper Distributors, Inc
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength4 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 53145-333-15

1 BOTTLE, DROPPER in 1 CARTON (53145-333-15) > 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53145-333-15 [53145033315]

Defensol-ito SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE4 mg/mL

OpenFDA Data

SPL SET ID:a7c7a60d-d49f-4239-92f7-714eac7eb0c5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1661314

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