Toenail Fungus Treatment Liquid
NDC Package 85569-005-01

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

Package Information

Toenail Fungus Treatment (25% undecylenic acid) liquids is helps inhibit the growth of fungus.Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness. This formulation utilizes a liquid delivery system. Marketed by 100 Karma Inc, this product is identified by NDC 85569-005 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85569-005-01
Package Description
30 mL in 1 CARTON
Product Code
85569-005
11-Digit Billing Format
85569000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Toenail Fungus Treatment
Non-Proprietary Name
25% Undecylenic Acid
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
Helps inhibit the growth of fungus.Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.

Regulatory & Marketing

Labeler Name
100 Karma Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-31-2025
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 85569-005-01 identifies a specific commercial package of 30 ml in 1 carton of Toenail Fungus Treatment, a human over the counter drug labeled by 100 Karma Inc. 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 100 Karma Inc on August 31, 2025. The current certification is valid through December 31, 2027.

How is this 100 Karma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85569000501. 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)
85569-005-01
11-Digit CMS (5-4-2)
85569-0005-01

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