Benzoyl Peroxide Liquid
NDC Package 35573-453-91

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

Benzoyl Peroxide liquids is a medication used to treat mild to moderate acne. This formulation utilizes a liquid delivery system. Marketed by Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-453 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
35573-453-91
Package Description
148 mL in 1 BOTTLE
Product Code
35573-453
11-Digit Billing Format
35573045391
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Benzoyl Peroxide
Non-Proprietary Name
Benzoyl Peroxide
Substance Name
Benzoyl Peroxide
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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)
BENZOYL PEROXIDE 50 mg/mL
Usage Information
This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Burel Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-15-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (35573-453). Click a package code to view its specific billing and regulatory data.

35573-453-08
237 mL in 1 BOTTLE

* 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 35573-453-91 identifies a specific commercial package of 148 ml in 1 bottle of Benzoyl Peroxide, a human over the counter drug labeled by Burel Pharmaceuticals, Llc. This liquid is formulated for topical use and contains benzoyl peroxide 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 Burel Pharmaceuticals, Llc on April 15, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573045391. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
35573-453-91
11-Digit CMS (5-4-2)
35573-0453-91

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