First Degree Maximum Strength Burn Cream
NDC Package 24330-130-02

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

Package Information

First Degree Maximum Strength Burn (pramoxine hydrochloride) cream is adults and children 2 years of age and older:clean the affected areaapply to affected area not more than 3 to 4 times dailymay be covered with a sterile bandagechildren under 2 years of age: ask a doctor. This formulation utilizes a cream delivery system. Marketed by Welmedix Llc, this product is identified by NDC 24330-130 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
24330-130-02
Package Description
1 TUBE in 1 BOX / 21 g in 1 TUBE
Product Code
24330-130
11-Digit Billing Format
24330013002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
First Degree Maximum Strength Burn
Non-Proprietary Name
Pramoxine Hydrochloride
Substance Name
Pramoxine Hydrochloride
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)
PRAMOXINE HYDROCHLORIDE 10 mg/g
Usage Information
Adults and children 2 years of age and older:clean the affected areaapply to affected area not more than 3 to 4 times dailymay be covered with a sterile bandagechildren under 2 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Welmedix Llc
Product Type
Human Otc Drug
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-09-2017
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 24330-130-02 identifies a specific commercial package of 1 tube in 1 box / 21 g in 1 tube of First Degree Maximum Strength Burn, a human over the counter drug labeled by Welmedix Llc. This cream is formulated for topical use and contains pramoxine hydrochloride 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 Welmedix Llc on March 09, 2017. The current certification is valid through December 31, 2026.

How is this Welmedix Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24330013002. 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)
24330-130-02
11-Digit CMS (5-4-2)
24330-0130-02

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