NDC 52261-2500

Fiore Rx Antifungal ProPen

Undecylenic Acid

Fiore Rx Antifungal ProPen is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Cosco International, Inc.. The primary component is Undecylenic Acid.

Product ID52261-2500_08c5d7fd-ce4a-43da-9972-127cef00fe89
NDC52261-2500
Product TypeHuman Otc Drug
Proprietary NameFiore Rx Antifungal ProPen
Generic NameUndecylenic Acid
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2013-05-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameCosco International, Inc.
Substance NameUNDECYLENIC ACID
Active Ingredient Strength1 g/2g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52261-2500-1

1 TUBE, WITH APPLICATOR in 1 BOX (52261-2500-1) > 2 g in 1 TUBE, WITH APPLICATOR (52261-2500-0)
Marketing Start Date2013-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52261-2500-0 [52261250000]

Fiore Rx Antifungal ProPen LIQUID
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-21

NDC 52261-2500-1 [52261250001]

Fiore Rx Antifungal ProPen LIQUID
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
UNDECYLENIC ACID.5 g/2g

OpenFDA Data

SPL SET ID:5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1437982
  • 1437977
  • NDC Crossover Matching brand name "Fiore Rx Antifungal ProPen" or generic name "Undecylenic Acid"

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