Acne Clearing Sulfur Mask Cream
NDC Package 80861-001-01

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

Package Information

Acne Clearing Sulfur Mask (sulfur) cream is gently massage into clean wet skin for two to three minutes until mask turns light blueleave on for an additional 10 minutes, until dryrinse off with warm water and pat dryif you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortableuse 2-3 times per week, or as desiredavoid the eye and lip areas. This formulation utilizes a cream delivery system. Marketed by Acnefree, Llc, this product is identified by NDC 80861-001 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
80861-001-01
Package Description
1 TUBE in 1 CARTON / 48 g in 1 TUBE
Product Code
80861-001
11-Digit Billing Format
80861000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acne Clearing Sulfur Mask
Non-Proprietary Name
Sulfur
Substance Name
Sulfur
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
SULFUR 35 mg/g
Usage Information
Gently massage into clean wet skin for two to three minutes until mask turns light blueleave on for an additional 10 minutes, until dryrinse off with warm water and pat dryif you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortableuse 2-3 times per week, or as desiredavoid the eye and lip areas

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 80861-001-01 identifies a specific commercial package of 1 tube in 1 carton / 48 g in 1 tube of Acne Clearing Sulfur Mask, a human over the counter drug labeled by Acnefree, Llc. This cream is formulated for topical use and contains sulfur 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: 80861000101. 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)
80861-001-01
11-Digit CMS (5-4-2)
80861-0001-01

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