NDC 54312-125 Derman Antifungal
Zinc Undecylenate Cream Topical

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 54312-125?
    5. Derman Antifungal Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code54312-125
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Derman Antifungal
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Zinc Undecylenate
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Undecylenic Acid; Zinc Undecylenate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Compania Internacional De Comercio, S.a.p.i De C.v.
Labeler Code54312
SPL SET ID:0129d801-90f6-49fd-857f-27d6ba9fc66c
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part333C
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		08-12-2013
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC Code 54312-125-01

Package Description: 1 TUBE in 1 CARTON / 25 g in 1 TUBE

NDC Code 54312-125-02

Package Description: 1 TUBE in 1 CARTON / 50 g in 1 TUBE

Product Details

What is NDC 54312-125?

The NDC code 54312-125 is assigned by the FDA to the product Derman Antifungal which is a human over the counter drug product labeled by Compania Internacional De Comercio, S.a.p.i De C.v.. The generic name of Derman Antifungal is zinc undecylenate. The product's dosage form is cream and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 54312-125-01 1 tube in 1 carton / 25 g in 1 tube, 54312-125-02 1 tube in 1 carton / 50 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Derman Antifungal?

Wash the affected area and dry thoroughly.Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.Supervise children in the use of this product.For athlete's foot: Pay special attention to between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.Use daily for 4 weeks.If condition persists longer, consult a doctor.This product is not effective on the scalp or nails.

What are Derman Antifungal Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Derman Antifungal UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Derman Antifungal Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Derman Antifungal?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1435154 - undecylenic acid 5 % / zinc undecylenate 18 % Topical Cream
  • RxCUI: 1435154 - undecylenic acid 50 MG/ML / zinc undecylenate 180 MG/ML Topical Cream
  • RxCUI: 1435159 - Derman Antifungal 5 % / 18 % Topical Cream
  • RxCUI: 1435159 - undecylenic acid 50 MG/ML / zinc undecylenate 180 MG/ML Topical Cream [Derman]
  • RxCUI: 1435159 - Derman Antifungal (undecylenic acid 5 % / zinc undecylenate 18 % ) Topical Cream

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