Tolnaftate Cream 1% Antifungal Cream
NDC Package 69396-042-05

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

Package Information

Tolnaftate Cream 1% Antifungal (family wellness tolnaftate) cream is tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This formulation utilizes a cream delivery system. Marketed by Trifecta Pharmaceuticals Usa, Llc, this product is identified by NDC 69396-042 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
69396-042-05
Package Description
1 TUBE in 1 BOX / 15 g in 1 TUBE
Product Code
69396-042
11-Digit Billing Format
69396004205
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tolnaftate Cream 1% Antifungal
Non-Proprietary Name
Family Wellness Tolnaftate
Substance Name
Tolnaftate
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)
TOLNAFTATE 1 g/100g
Usage Information
Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Trifecta Pharmaceuticals Usa, Llc
Product Type
Human Otc Drug
FDA Application #
M005
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 69396-042-05 identifies a specific commercial package of 1 tube in 1 box / 15 g in 1 tube of Tolnaftate Cream 1% Antifungal, a human over the counter drug labeled by Trifecta Pharmaceuticals Usa, Llc. This cream is formulated for topical use and contains tolnaftate 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 Trifecta Pharmaceuticals Usa, Llc on August 30, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

How is this Trifecta Pharmaceuticals Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69396004205. 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)
69396-042-05
11-Digit CMS (5-4-2)
69396-0042-05

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