Acne Free Severe Acne 24 Hr Acne Clearing System Kit
NDC 80861-010

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 80861-010?
  4. Acne Free Severe Acne 24 Hr Acne Clearing System Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Acne Free Severe Acne 24 Hr Acne Clearing System (benzoyl peroxide) is a OTC MONOGRAPH DRUG-approved product labeled by Acnefree, Llc. This medication is used to treat mild to moderate acne. It is supplied as a kit. This product entry covers the primary NDC 80861-010 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
80861-010
Proprietary Name:
Acne Free Severe Acne 24 Hr Acne Clearing System
Non-Proprietary Name: [1]
Benzoyl Peroxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Acnefree, Llc
Labeler Code:
80861
Product Label ID:
c939681e-ea93-31ce-e053-2a95a90a8c70
FDA Application Number: [6]
M006
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
12-01-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 80861-010?

The NDC code 80861-010 is assigned by the FDA to the product Acne Free Severe Acne 24 Hr Acne Clearing System. It is commonly known by its generic name, benzoyl peroxide. This pharmaceutical product is labeled by Acnefree, Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 80861-010-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 106310 - benzoyl peroxide 10 % Topical Lotion
  • RxCUI: 106310 - benzoyl peroxide 100 MG/ML Topical Lotion
  • RxCUI: 2048989 - {1 (59 ML) (benzoyl peroxide 100 MG/ML Topical Lotion) / 1 (118 ML) (benzoyl peroxide 25 MG/ML Medicated Liquid Soap) } Pack
  • RxCUI: 2048989 - benzoyl peroxide 2.5 % Medicated Liquid Soap (4 OZ) / benzoyl peroxide 10 % Topical Lotion (2 OZ) Pack
  • RxCUI: 845836 - benzoyl peroxide 2.5 % Medicated Liquid Soap

* Please review the full disclaimer at the bottom of this page.

Patient Education

Benzoyl Peroxide Topical


Benzoyl peroxide is used to treat mild to moderate acne.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".