Methyl Salicylate 10% Patch
NDC Package 85231-101-15

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

Package Information

Methyl Salicylate 10% (methyl salicylate) patches is adults and Children 10 years of age and older:only use one patch at a timeclean and dry affected arearemove patch from backing film and apply to skin (see illustration)apply 1 patch to the affective area of intact skin up to 24 hours.do not use more than 2 patches per day  do not use for more than 3 days in a rowthe used patch should be removed from the skin when a new one is applied. This formulation utilizes a patch delivery system. Marketed by Violacare, Inc., this product is identified by NDC 85231-101 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
85231-101-15
Package Description
15 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 10 g in 1 PATCH
Product Code
85231-101
11-Digit Billing Format
85231010115
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methyl Salicylate 10%
Non-Proprietary Name
Methyl Salicylate
Substance Name
Methyl Salicylate
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)
METHYL SALICYLATE 10 g/100g
Usage Information
Adults and Children 10 years of age and older:only use one patch at a timeclean and dry affected arearemove patch from backing film and apply to skin (see illustration)apply 1 patch to the affective area of intact skin up to 24 hours.do not use more than 2 patches per day  do not use for more than 3 days in a rowthe used patch should be removed from the skin when a new one is applied

Regulatory & Marketing

Labeler Name
Violacare, Inc.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2025
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 85231-101-15 identifies a specific commercial package of 15 pouch in 1 box / 1 patch in 1 pouch / 10 g in 1 patch of Methyl Salicylate 10%, a human over the counter drug labeled by Violacare, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This patch is formulated for topical use and contains 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 Violacare, Inc. on May 01, 2025. The current certification is valid through December 31, 2026.

How is this Violacare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85231010115. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
85231-101-15
11-Digit CMS (5-4-2)
85231-0101-15

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