Berberex Wound Gel
NDC Package 52261-0601-1

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

Package Information

Berberex Wound Gel (benzethonium chloride, allantoin) gel is adults and children 2 years of age and older:• Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or BerbereX® wound cleanser and let air dry• Apply appropriate layer of the gel to cover the affected area• Cover with adhesive bandage or sterile gauze if needed• Apply 1 to 3 times daily• Children under 2 years of age: ask a doctor. This formulation utilizes a gel delivery system. Marketed by Cosco International, Inc., this product is identified by NDC 52261-0601 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
52261-0601-1
Package Description
.085 kg in 1 TUBE
Product Code
52261-0601
11-Digit Billing Format
52261060101

Clinical Specifications

Proprietary Name
Berberex Wound Gel
Non-Proprietary Name
Benzethonium Chloride, Allantoin
Substance Name
Allantoin; Benzethonium Chloride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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
Adults and children 2 years of age and older:• Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or BerbereX® wound cleanser and let air dry• Apply appropriate layer of the gel to cover the affected area• Cover with adhesive bandage or sterile gauze if needed• Apply 1 to 3 times daily• Children under 2 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Cosco International, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2022
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 52261-0601-1 identifies a specific commercial package of .085 kg in 1 tube of Berberex Wound Gel, a human over the counter drug labeled by Cosco International, Inc.. This gel is formulated for topical use and contains allantoin; benzethonium chloride 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 Cosco International, Inc. on July 01, 2022. The current certification is valid through December 31, 2026.

How is this Cosco International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52261060101. 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 (5-4-1)
52261-0601-1
11-Digit CMS (5-4-2)
52261-0601-01

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