Dermaharmony 10% Sulfur Soap
NDC Package 71819-014-04

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

Dermaharmony 10% Sulfur (sulfur) soaps is usesFor the treatment of acne.Clears acne blemishes, blackheads, and whiteheads. This formulation utilizes a soap delivery system. Marketed by D3 Development, Inc., this product is identified by NDC 71819-014 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
71819-014-04
Package Description
113 g in 1 POUCH
Product Code
71819-014
11-Digit Billing Format
71819001404
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermaharmony 10% Sulfur
Non-Proprietary Name
Sulfur
Substance Name
Sulfur
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)
SULFUR 10 g/100g
Usage Information
UsesFor the treatment of acne.Clears acne blemishes, blackheads, and whiteheads.

Regulatory & Marketing

Labeler Name
D3 Development, Inc.
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-20-2021
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 (71819-014). Click a package code to view its specific billing and regulatory data.

71819-014-05
113 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 71819-014-04 identifies a specific commercial package of 113 g in 1 pouch of Dermaharmony 10% Sulfur, a human over the counter drug labeled by D3 Development, Inc.. This soap 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 D3 Development, Inc. on July 20, 2021. The current certification is valid through December 31, 2026.

How is this D3 Development, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71819001404. 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)
71819-014-04
11-Digit CMS (5-4-2)
71819-0014-04

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