Tolnaftate Cream
NDC Package 79458-003-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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 Natural Technology Llc, this product is identified by NDC 79458-003.

Identification & Billing

NDC Package Code
79458-003-01
Package Description
113 g in 1 TUBE
Product Code
79458-003
11-Digit Billing Format
79458000301

Clinical Specifications

Proprietary Name
Tolnaftate
Non-Proprietary Name
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.
Active Ingredient(s)
TOLNAFTATE 10 g/1000g
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
Natural Technology Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 79458-003-01 identifies a specific commercial package of 113 g in 1 tube of Tolnaftate (UNFINISHED drug), drug for further processing labeled by Natural Technology Llc. This cream is formulated for 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 Natural Technology Llc on January 01, 2025. 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 Natural Technology Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79458000301. 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)
79458-003-01
11-Digit CMS (5-4-2)
79458-0003-01

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