NDC 0295-9008

CVS Maximum Strength Anti-Fungal Pen 25%

Undecylenic Acid

CVS Maximum Strength Anti-Fungal Pen 25% is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Llc. The primary component is Undecylenic Acid.

Product ID0295-9008_7ee60b49-f130-a0e1-e053-2991aa0a356e
NDC0295-9008
Product TypeHuman Otc Drug
Proprietary NameCVS Maximum Strength Anti-Fungal Pen 25%
Generic NameUndecylenic Acid
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2019-01-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameDenison Pharmaceuticals, LLC
Substance NameUNDECYLENIC ACID
Active Ingredient Strength25 mg/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0295-9008-16

3 mL in 1 TUBE, WITH APPLICATOR (0295-9008-16)
Marketing Start Date2019-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0295-9008-16 [00295900816]

CVS Maximum Strength Anti-Fungal Pen 25% LIQUID
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-09

Drug Details

Active Ingredients

IngredientStrength
UNDECYLENIC ACID25 mg/100mL

OpenFDA Data

SPL SET ID:7ee60b49-f12f-a0e1-e053-2991aa0a356e
Manufacturer
UNII

NDC Crossover Matching brand name "CVS Maximum Strength Anti-Fungal Pen 25%" or generic name "Undecylenic Acid"

NDCBrand NameGeneric Name
0295-9008CVS Maximum Strength Anti-Fungal Pen 25%Undecylenic acid
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