Methyl Salicylate Cream
NDC Package 50488-1015-5

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

Methyl Salicylate cream is  adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor. This formulation utilizes a cream delivery system. Marketed by Alexso, Inc, this product is identified by NDC 50488-1015 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
50488-1015-5
Package Description
50 g in 1 BOTTLE
Product Code
50488-1015
11-Digit Billing Format
50488101505
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methyl Salicylate
Non-Proprietary Name
Methyl Salicylate
Substance Name
Methyl Salicylate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 250 mg/g
Usage Information
 adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor

Regulatory & Marketing

Labeler Name
Alexso, Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50488-1015). Click a package code to view its specific billing and regulatory data.

50488-1015-1
120 g 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 50488-1015-5 identifies a specific commercial package of 50 g in 1 bottle of Methyl Salicylate, a human over the counter drug labeled by Alexso, Inc. This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package. This cream 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 April 01, 2019. 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: 50488101505. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 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)
50488-1015-5
11-Digit CMS (5-4-2)
50488-1015-05

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