Acne Free Sensitive Skin 24 Hr Acne Clearing System Kit
NDC Package 80861-007-01

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

Package Information

Acne Free Sensitive Skin 24 Hr Acne Clearing System (salicylic acid, benzoyl peroxide) kits is • use every morning and evening • apply a dime-size amount to damp skin and gently massage, avoiding the eye area • rinse well • if bothersome dryness or peeling occurs, reduce application use • may be used on chest or back • clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor. This formulation utilizes a kit delivery system. Marketed by Acnefree Llc, this product is identified by NDC 80861-007 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
80861-007-01
Package Description
1 KIT in 1 KIT * 118 mL in 1 BOTTLE (80861-008-01) * 59 mL in 1 BOTTLE (80861-009-01)
Product Code
80861-007
11-Digit Billing Format
80861000701
RxNorm Crosswalk
  • RxCUI: 1234456 - salicylic acid 1.5 % Medicated Liquid Soap
  • RxCUI: 1234456 - salicylic acid 15 MG/ML Medicated Liquid Soap
  • RxCUI: 1548871 - benzoyl peroxide 3 % Topical Lotion
  • RxCUI: 1548871 - benzoyl peroxide 30 MG/ML Topical Lotion
  • RxCUI: 1549098 - {1 (59 ML) (benzoyl peroxide 30 MG/ML Topical Lotion) / 1 (118 ML) (salicylic acid 15 MG/ML Medicated Liquid Soap) } Pack

Clinical Specifications

Proprietary Name
Acne Free Sensitive Skin 24 Hr Acne Clearing System
Non-Proprietary Name
Salicylic Acid, Benzoyl Peroxide
Dosage Form
Kit - A packaged collection of related material.
Usage Information
• use every morning and evening • apply a dime-size amount to damp skin and gently massage, avoiding the eye area • rinse well • if bothersome dryness or peeling occurs, reduce application use • may be used on chest or back • clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Regulatory & Marketing

Labeler Name
Acnefree Llc
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2017
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 80861-007-01 identifies a specific commercial package of 1 kit in 1 kit * 118 ml in 1 bottle (80861-008-01) * 59 ml in 1 bottle (80861-009-01) of Acne Free Sensitive Skin 24 Hr Acne Clearing System, a human over the counter drug labeled by Acnefree Llc. This kit is formulated for use and contains 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 Acnefree Llc on December 01, 2017. The current certification is valid through December 31, 2026.

How is this Acnefree Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80861000701. 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)
80861-007-01
11-Digit CMS (5-4-2)
80861-0007-01

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