Dermagesic Cream
NDC Package 54859-202-04

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

Package Information

Dermagesic (pramoxine hcl, zinc oxide, calamine) cream is adults and children 2 years of age and older apply to affected area not more than 3 to 4 times dailyChildren under 2 years of age ask a doctorDo not use more often than directed. This formulation utilizes a cream delivery system. Marketed by Llorens Pharmaceutical International Division, this product is identified by NDC 54859-202 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
54859-202-04
Package Description
113 g in 1 JAR
Product Code
54859-202
11-Digit Billing Format
54859020204
RxNorm Crosswalk
  • RxCUI: 1798481 - pramoxine HCl 1 % / zinc oxide 0.4 % / calamine 0.4 % Topical Cream
  • RxCUI: 1798481 - calamine 4 MG/ML / pramoxine hydrochloride 10 MG/ML / zinc oxide 4 MG/ML Topical Cream
  • RxCUI: 1798481 - calamine 0.4 % / pramoxine HCl 1 % / zinc oxide 0.4 % Topical Cream
  • RxCUI: 1798481 - Calamine 4 MG/ML / Pramoxine hydrochloride 10 MG/ML / ZNO 4 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Dermagesic
Non-Proprietary Name
Pramoxine Hcl, Zinc Oxide, Calamine
Substance Name
Ferric Oxide Red; Pramoxine Hydrochloride; Zinc Oxide
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)
Pharmacologic Class
Usage Information
Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times dailyChildren under 2 years of age ask a doctorDo not use more often than directed

Regulatory & Marketing

Labeler Name
Llorens Pharmaceutical International Division
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54859-202-04 identifies a specific commercial package of 113 g in 1 jar of Dermagesic, a human over the counter drug labeled by Llorens Pharmaceutical International Division. This cream is formulated for topical use and contains ferric oxide red; pramoxine hydrochloride; zinc oxide 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 Llorens Pharmaceutical International Division on April 01, 2016. The current certification is valid through December 31, 2026.

How is this Llorens Pharmaceutical International Division product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54859020204. 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)
54859-202-04
11-Digit CMS (5-4-2)
54859-0202-04

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