Tinea Versicolor Treatment Cream
NDC Package 85398-002-01

11-digit billing NDC: 85398000201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tinea Versicolor Treatment Cream (clotrimazole) cream is helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections. This formulation utilizes a cream delivery system. Marketed by Beautivity Llc, this product is identified by NDC 85398-002 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85398-002-01
Package Description
60 g in 1 TUBE
Product Code
85398-002
11-Digit Billing Format
85398000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tinea Versicolor Treatment Cream
Non-Proprietary Name
Clotrimazole
Substance Name
Clotrimazole
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)
CLOTRIMAZOLE 10 mg/g
Pharmacologic Class
Usage Information
Helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections.

Regulatory & Marketing

Labeler Name
Beautivity Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-12-2025
Listing Expiration
12-31-2027
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 85398-002-01 identifies a specific commercial package of 60 g in 1 tube of Tinea Versicolor Treatment Cream, a human over the counter drug labeled by Beautivity Llc. This cream is formulated for topical use and contains clotrimazole 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 Beautivity Llc on May 12, 2025. The current certification is valid through December 31, 2027.

How is this Beautivity Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85398000201. 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)
85398-002-01
11-Digit CMS (5-4-2)
85398-0002-01

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