Tegasolve Toenail Fungus Treatment Liquid
NDC Package 85578-003-01

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

Package Information

Tegasolve Toenail Fungus Treatment (undecylenic acid 25%) liquids is for the effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails. This formulation utilizes a liquid delivery system. Marketed by Zhengzhou Hangrui Network Technology Co., Ltd., this product is identified by NDC 85578-003 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85578-003-01
Package Description
1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE
Product Code
85578-003
11-Digit Billing Format
85578000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tegasolve Toenail Fungus Treatment
Non-Proprietary Name
Undecylenic Acid 25%
Substance Name
Undecylenic Acid
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)
UNDECYLENIC ACID 25 g/100mL
Usage Information
For the effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails

Regulatory & Marketing

Labeler Name
Zhengzhou Hangrui Network Technology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-12-2025
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 85578-003-01 identifies a specific commercial package of 1 bottle in 1 box / 30 ml in 1 bottle of Tegasolve Toenail Fungus Treatment, a human over the counter drug labeled by Zhengzhou Hangrui Network Technology Co., Ltd.. This liquid is formulated for topical use and contains undecylenic acid 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 Zhengzhou Hangrui Network Technology Co., Ltd. on June 12, 2025. The current certification is valid through December 31, 2026.

How is this Zhengzhou Hangrui Network Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85578000301. 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)
85578-003-01
11-Digit CMS (5-4-2)
85578-0003-01

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