Treatonic Nailtonic Repair Pens Gel
NDC Package 85569-015-01

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

Package Information

Treatonic Nailtonic Repair Pens (25% undecylenic acid) gel is wash affected area and dry thoroughly. This formulation utilizes a gel delivery system. Marketed by 100 Karma Inc, this product is identified by NDC 85569-015 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85569-015-01
Package Description
45 g in 1 CARTON
Product Code
85569-015
11-Digit Billing Format
85569001501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Treatonic Nailtonic Repair Pens
Non-Proprietary Name
25% Undecylenic Acid
Substance Name
Undecylenic Acid
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 11.25 g/45g
Usage Information
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.

Regulatory & Marketing

Labeler Name
100 Karma Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-05-2026
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 85569-015-01 identifies a specific commercial package of 45 g in 1 carton of Treatonic Nailtonic Repair Pens, a human over the counter drug labeled by 100 Karma Inc. This gel 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 March 05, 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: 85569001501. 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)
85569-015-01
11-Digit CMS (5-4-2)
85569-0015-01

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