Slmd Silver Sulfur Acne Cream
NDC Package 59958-407-02

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

Package Information

Slmd Silver Sulfur Acne Cream (sulfur) cream is • clean the skin thoroughly beforeapplying this product• cover the entire affected area witha thin layer one to three timesdaily • because excessive dryingof the skin may occur, start withone applicagtion daily, thengradually increase to two or threetimes daily if needed or asdirected by a doctor• if bothersome dryness or peelingoccurs, reduce application toonce a day or every other day• Sensitivity Test for a New User:Apply product sparingly to one ortwo small affected areas duringthe first 3 days. This formulation utilizes a cream delivery system. Marketed by Owen Biosciences Inc., this product is identified by NDC 59958-407 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
59958-407-02
Package Description
1 BOTTLE in 1 CARTON / 50 g in 1 BOTTLE (59958-407-01)
Product Code
59958-407
11-Digit Billing Format
59958040702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Slmd Silver Sulfur Acne Cream
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 3 g/100g
Usage Information
• clean the skin thoroughly beforeapplying this product• cover the entire affected area witha thin layer one to three timesdaily • because excessive dryingof the skin may occur, start withone applicagtion daily, thengradually increase to two or threetimes daily if needed or asdirected by a doctor• if bothersome dryness or peelingoccurs, reduce application toonce a day or every other day• Sensitivity Test for a New User:Apply product sparingly to one ortwo small affected areas duringthe first 3 days. If no discomfortoccurs, follow the directionsstated above.

Regulatory & Marketing

Labeler Name
Owen Biosciences Inc.
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-30-2019
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 59958-407-02 identifies a specific commercial package of 1 bottle in 1 carton / 50 g in 1 bottle (59958-407-01) of Slmd Silver Sulfur Acne Cream, a human over the counter drug labeled by Owen Biosciences Inc.. 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 Owen Biosciences Inc. on August 30, 2019. The current certification is valid through December 31, 2026.

How is this Owen Biosciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59958040702. 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)
59958-407-02
11-Digit CMS (5-4-2)
59958-0407-02

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