NDC 54312-925

DERMAN ANTIFUNGAL

Zinc Undecylenate, Undecylenic Acid

DERMAN ANTIFUNGAL is a Topical Powder in the Human Otc Drug category. It is labeled and distributed by Compania Internacional De Comercio, S.a.p.i. De C.v.. The primary component is Undecylenic Acid; Zinc Undecylenate.

• Product ID: 54312-925_7d7c71fb-0ccc-614a-e053-2a91aa0ae575
• NDC: 54312-925
• Product Type: Human Otc Drug
• Proprietary Name: DERMAN ANTIFUNGAL
• Generic Name: Zinc Undecylenate, Undecylenic Acid
• Dosage Form: Powder
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-09-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part333C
• Labeler Name: Compania Internacional de Comercio, S.A.P.I. de C.V.
• Substance Name: UNDECYLENIC ACID; ZINC UNDECYLENATE
• Active Ingredient Strength: 2 g/100g; g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54312-925-01

1 BOTTLE in 1 PACKAGE (54312-925-01) > 80 g in 1 BOTTLE

• Marketing Start Date: 2017-12-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54312-925-01 [54312092501]

DERMAN ANTIFUNGAL POWDER

• Marketing Category: OTC monograph final
• Application Number: part333C
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-12-26

Drug Details

Active Ingredients

Ingredient	Strength
UNDECYLENIC ACID	2 g/100g

OpenFDA Data

• SPL SET ID: 6169af3c-cc90-484d-a0f5-14f5f9ae0a6f
• Manufacturer:
  • Compania Internacional de Comercio, S.A.P.I. de C.V.
• UNII:
  • 388VZ25DUR
  • K3D86KJ24N
• RxNorm Concept Unique ID - RxCUI:
  • 1993231
  • 313817
• UPC Code:
  • 0354312425014

NDC Crossover Matching brand name "DERMAN ANTIFUNGAL" or generic name "Zinc Undecylenate, Undecylenic Acid"

NDC	Brand Name	Generic Name
54312-125	Derman Antifungal	ZINC UNDECYLENATE
54312-325	DERMAN ANTIFUNGAL	UNDECYLENIC ACID
54312-925	DERMAN ANTIFUNGAL	ZINC UNDECYLENATE, UNDECYLENIC ACID
69772-125	DERMAN ANTIFUNGAL	ZINC UNDECYLENATE