Derman Antifungal Cream
NDC Package 54312-125-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Derman Antifungal (zinc undecylenate) cream is 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. This formulation utilizes a cream delivery system. Marketed by Compania Internacional De Comercio, S.a.p.i De C.v., this product is identified by NDC 54312-125 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
54312-125-01
Package Description
1 TUBE in 1 CARTON / 25 g in 1 TUBE
Product Code
54312-125
11-Digit Billing Format
54312012501
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Derman Antifungal
Non-Proprietary Name
Zinc Undecylenate
Substance Name
Undecylenic Acid; Zinc Undecylenate
Dosage Form
Cream - 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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Compania Internacional De Comercio, S.a.p.i De C.v.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-12-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54312-125). Click a package code to view its specific billing and regulatory data.

54312-125-02
1 TUBE in 1 CARTON / 50 g in 1 TUBE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54312-125-01 identifies a specific commercial package of 1 tube in 1 carton / 25 g in 1 tube of Derman Antifungal, a human over the counter drug labeled by Compania Internacional De Comercio, S.a.p.i De C.v.. This cream is formulated for topical use and contains undecylenic acid; zinc undecylenate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Compania Internacional De Comercio, S.a.p.i De C.v. on August 12, 2013. The current certification is valid through December 31, 2026.

How is this Compania Internacional De Comercio, S.a.p.i De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54312012501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
54312-125-01
11-Digit CMS (5-4-2)
54312-0125-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.