Tolfyra Liquid
NDC Package 85477-331-01

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

Package Information

Tolfyra (tolnaftate) liquids is tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This formulation utilizes a liquid delivery system. Marketed by Oncora Pharma, Llc, this product is identified by NDC 85477-331 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85477-331-01
Package Description
30 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
85477-331
11-Digit Billing Format
85477033101

Clinical Specifications

Proprietary Name
Tolfyra
Non-Proprietary Name
Tolnaftate
Substance Name
Tolnaftate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 .3 g/30mL
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
Oncora Pharma, Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2026
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 85477-331-01 identifies a specific commercial package of 30 ml in 1 bottle, with applicator of Tolfyra, a human over the counter drug labeled by Oncora Pharma, Llc. This liquid 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 Oncora Pharma, Llc on May 01, 2026. The current certification is valid through December 31, 2027.

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 Oncora Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85477033101. 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)
85477-331-01
11-Digit CMS (5-4-2)
85477-0331-01

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