Methyl Salicylate Patch
NDC Package 50488-2010-1

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 and children 18 years of age and older:Apply 1 patch to the affected area of intact skin up to 3 times a day. This formulation utilizes a patch delivery system. Marketed by Alexso, Inc, this product is identified by NDC 50488-2010 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
50488-2010-1
Package Description
2 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 100 g in 1 PATCH
Product Code
50488-2010
11-Digit Billing Format
50488201001
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 10 g/100g
Usage Information
Adults and children 18 years of age and older:Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area.- Open pouch and remove one patch.- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches.- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years: Ask a physician

Regulatory & Marketing

Labeler Name
Alexso, Inc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-11-2021
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 50488-2010-1 identifies a specific commercial package of 2 pouch in 1 box / 5 patch in 1 pouch / 100 g in 1 patch of Methyl Salicylate, a human over the counter drug labeled by Alexso, 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 Alexso, Inc on February 11, 2021. The current certification is valid through December 31, 2026.

How is this Alexso, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50488201001. 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 (5-4-1)
50488-2010-1
11-Digit CMS (5-4-2)
50488-2010-01

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