Shaant Spot Hero Drying Acne Treatment Gel
NDC Package 83196-690-12

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

Package Information

Shaant Spot Hero Drying Acne Treatment (sulfur) gel is clean the skin thoroughly before applying this product cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. This formulation utilizes a gel delivery system. Marketed by Codex Labs Corporation, this product is identified by NDC 83196-690 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
83196-690-12
Package Description
1 TUBE in 1 CARTON / 15 mL in 1 TUBE
Product Code
83196-690
11-Digit Billing Format
83196069012
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Shaant Spot Hero Drying Acne Treatment
Non-Proprietary Name
Sulfur
Substance Name
Sulfur
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 50 mg/mL
Usage Information
Clean the skin thoroughly before applying this product cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.

Regulatory & Marketing

Labeler Name
Codex Labs Corporation
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-15-2023
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 83196-690-12 identifies a specific commercial package of 1 tube in 1 carton / 15 ml in 1 tube of Shaant Spot Hero Drying Acne Treatment, a human over the counter drug labeled by Codex Labs Corporation. This gel 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 Codex Labs Corporation on May 15, 2023. The current certification is valid through December 31, 2026.

How is this Codex Labs Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83196069012. 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)
83196-690-12
11-Digit CMS (5-4-2)
83196-0690-12

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