Panoxyl Soap
NDC Package 0316-0264-04

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

Panoxyl (benzoyl peroxide) soaps is a medication used to treat mild to moderate acne. This formulation utilizes a soap delivery system. Marketed by Crown Laboratories, this product is identified by NDC 0316-0264 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
0316-0264-04
Package Description
113 g in 1 CARTON
Product Code
0316-0264
11-Digit Billing Format
00316026404
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Panoxyl
Non-Proprietary Name
Benzoyl Peroxide
Substance Name
Benzoyl Peroxide
Dosage Form
Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.
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 12.6 g/113g
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
Crown Laboratories
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2023
Listing Expiration
12-31-2027
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 (0316-0264). Click a package code to view its specific billing and regulatory data.

0316-0264-01
43 g in 1 CARTON

* 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 0316-0264-04 identifies a specific commercial package of 113 g in 1 carton of Panoxyl, a human over the counter drug labeled by Crown Laboratories. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This soap 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 Crown Laboratories on July 01, 2023. The current certification is valid through December 31, 2027.

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 Crown Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00316026404. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (4-4-2)
0316-0264-04
11-Digit CMS (5-4-2)
00316-0264-04

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