Methyl Salicylate Patch
NDC Package 79643-003-01

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

Package Information

Methyl Salicylate patches is  Adults 18 years and older: • Clean and dry affected area • Only use one patch at a time • Remove patch from backing film and apply to skin • Apply one patch to the affected area and leave in place for up to 8 to 12 hours • If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • Do not use more than 2 patches per day • Do not use for more than 3 days in a row • The used patch should be removed from the skin when a new one is applied • Children under 18 years of age: do not use: this product has not been shown to work in children. This formulation utilizes a patch delivery system. Marketed by Pharmacure Llc, this product is identified by NDC 79643-003 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
79643-003-01
Package Description
2 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 1000 mg in 1 PATCH
Product Code
79643-003
11-Digit Billing Format
79643000301
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
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 100 mg/1000mg
Usage Information
 Adults 18 years and older: • Clean and dry affected area • Only use one patch at a time • Remove patch from backing film and apply to skin • Apply one patch to the affected area and leave in place for up to 8 to 12 hours • If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • Do not use more than 2 patches per day • Do not use for more than 3 days in a row • The used patch should be removed from the skin when a new one is applied • Children under 18 years of age: do not use: this product has not been shown to work in children

Regulatory & Marketing

Labeler Name
Pharmacure Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-17-2023
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 79643-003-01 identifies a specific commercial package of 2 pouch in 1 box / 5 patch in 1 pouch / 1000 mg in 1 patch of Methyl Salicylate, a human over the counter drug labeled by Pharmacure Llc. 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 Pharmacure Llc on February 17, 2023. The current certification is valid through December 31, 2026.

How is this Pharmacure Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79643000301. 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)
79643-003-01
11-Digit CMS (5-4-2)
79643-0003-01

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