Pain Relief Gel-roll On Gel
NDC Package 69396-185-01

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

Package Information

Pain Relief Gel-roll On (menthol) gel is adults and children over 12 years: apply to the affected area not more than 3 to 4 times daily.Children 12 years or younger: ask a doctorAfter applying wash hands with soap and water. This formulation utilizes a gel delivery system. Marketed by Trifecta Pharmaceuticals Usa, this product is identified by NDC 69396-185 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
69396-185-01
Package Description
1 BOTTLE in 1 BOX / .073 L in 1 BOTTLE
Product Code
69396-185
11-Digit Billing Format
69396018501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pain Relief Gel-roll On
Non-Proprietary Name
Menthol
Substance Name
Lidocaine; Menthol
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)
Pharmacologic Class
Usage Information
Adults and children over 12 years: apply to the affected area not more than 3 to 4 times daily.Children 12 years or younger: ask a doctorAfter applying wash hands with soap and water

Regulatory & Marketing

Labeler Name
Trifecta Pharmaceuticals Usa
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-27-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69396-185). Click a package code to view its specific billing and regulatory data.

69396-185-03
3 BOTTLE in 1 BOX / .073 L in 1 BOTTLE

* 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 69396-185-01 identifies a specific commercial package of 1 bottle in 1 box / .073 l in 1 bottle of Pain Relief Gel-roll On, a human over the counter drug labeled by Trifecta Pharmaceuticals Usa. This gel is formulated for topical use and contains lidocaine; 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 Trifecta Pharmaceuticals Usa on April 27, 2026. The current certification is valid through December 31, 2027.

How is this Trifecta Pharmaceuticals Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69396018501. 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)
69396-185-01
11-Digit CMS (5-4-2)
69396-0185-01

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