Rugged Fit Pain Relief Roll On Gel
NDC Package 85826-041-10

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

Package Information

Rugged Fit Pain Relief Roll On (menthol, methyl salicylate) gel is temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises. This formulation utilizes a gel delivery system. Marketed by System4book Llc, this product is identified by NDC 85826-041 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
85826-041-10
Package Description
100 mL in 1 BOTTLE
Product Code
85826-041
11-Digit Billing Format
85826004110
RxNorm Crosswalk
  • RxCUI: 2711803 - menthol 2 % / methyl salicylate 10 % Topical Gel
  • RxCUI: 2711803 - menthol 0.02 MG/MG / methyl salicylate 0.1 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Rugged Fit Pain Relief Roll On
Non-Proprietary Name
Menthol, Methyl Salicylate
Substance Name
Menthol; Methyl Salicylate
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)
Usage Information
Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

Regulatory & Marketing

Labeler Name
System4book Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-27-2025
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 85826-041-10 identifies a specific commercial package of 100 ml in 1 bottle of Rugged Fit Pain Relief Roll On, a human over the counter drug labeled by System4book Llc. This gel is formulated for topical use and contains menthol; methyl salicylate 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 System4book Llc on June 27, 2025. The current certification is valid through December 31, 2026.

How is this System4book Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85826004110. 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)
85826-041-10
11-Digit CMS (5-4-2)
85826-0041-10

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