Menthol Pain Relief Gel Patch
NDC Package 55629-025-15

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

Package Information

Menthol Pain Relief Gel Patch patches is adult and children over 12years:Clean and dry affected arearemove backing from patch by firmly grasping both ends and gently pulling until back separates in middlecarefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected areado not wear a patch for more than 8 hoursapply affected area no more than 3 times dailychildren 12 years or younger: ask a doctor. This formulation utilizes a patch delivery system. Marketed by One2zee Limited Liability Company, this product is identified by NDC 55629-025 and is authorized under FDA application M.

Identification & Billing

NDC Package Code
55629-025-15
Package Description
3 POUCH in 1 BOX / 5 PATCH in 1 POUCH
Product Code
55629-025
11-Digit Billing Format
55629002515
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Menthol Pain Relief Gel Patch
Non-Proprietary Name
Menthol Pain Relief Gel Patch
Substance Name
Menthol
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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)
MENTHOL 50 mg/1
Usage Information
Adult and children over 12years:Clean and dry affected arearemove backing from patch by firmly grasping both ends and gently pulling until back separates in middlecarefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected areado not wear a patch for more than 8 hoursapply affected area no more than 3 times dailychildren 12 years or younger: ask a doctor

Regulatory & Marketing

Labeler Name
One2zee Limited Liability Company
Product Type
Human Otc Drug
FDA Application #
M
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-04-2025
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 55629-025-15 identifies a specific commercial package of 3 pouch in 1 box / 5 patch in 1 pouch of Menthol Pain Relief Gel Patch, a human over the counter drug labeled by One2zee Limited Liability Company. This patch is formulated for topical use and contains menthol 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 One2zee Limited Liability Company on March 04, 2025. The current certification is valid through December 31, 2026.

How is this One2zee Limited Liability Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55629002515. 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)
55629-025-15
11-Digit CMS (5-4-2)
55629-0025-15

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