Treatonic Tonenail Fungus Treatonic Kit. Kit
NDC Package 85569-016-01

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

Package Information

Treatonic Tonenail Fungus Treatonic Kit. (25% undecylenic acid and tolnaftate 1%) kits is directions (Treatment)Wash affected area and dry thoroughly.Apply a thin layer of the product over the affected area(around the nails and underneath nail tips) twice daily or directed by a doctor.Supervise children in the use of this product. This formulation utilizes a kit delivery system. Marketed by 100 Karma Inc, this product is identified by NDC 85569-016 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85569-016-01
Package Description
1 KIT in 1 CARTON
Product Code
85569-016
11-Digit Billing Format
85569001601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Treatonic Tonenail Fungus Treatonic Kit.
Non-Proprietary Name
25% Undecylenic Acid And Tolnaftate 1%
Dosage Form
Kit - A packaged collection of related material.
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.
Usage Information
Directions (Treatment)Wash affected area and dry thoroughly.Apply a thin layer of the product over the affected area(around the nails and underneath nail tips) twice daily or directed by a doctor.Supervise children in the use of this product. Directions (Patch) Clean & prepare the affected nail.Apply the antifungal solution to the affected nall.Apply the fungusnail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips,Leave the patch on for 6-8 hours. Frequency. Use the patches consistently before bed.Maintain good foot hygiene.

Regulatory & Marketing

Labeler Name
100 Karma Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-24-2026
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 85569-016-01 identifies a specific commercial package of 1 kit in 1 carton of Treatonic Tonenail Fungus Treatonic Kit., a human over the counter drug labeled by 100 Karma Inc. This kit is formulated for topical use and contains 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 March 24, 2026. 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: 85569001601. 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)
85569-016-01
11-Digit CMS (5-4-2)
85569-0016-01

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