Methyl Salicylate 25% Cream
NDC Package 85477-301-10

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

Package Information

Methyl Salicylate 25% (methyl salicylate) cream is for the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.This product is used as. This formulation utilizes a cream delivery system. Marketed by Oncora Pharma, Llc, this product is identified by NDC 85477-301 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
85477-301-10
Package Description
118 mL in 1 BOTTLE, PUMP
Product Code
85477-301
11-Digit Billing Format
85477030110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methyl Salicylate 25%
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/mL
Usage Information
For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.This product is used as . Topical Analgesic

Regulatory & Marketing

Labeler Name
Oncora Pharma, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-11-2025
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 85477-301-10 identifies a specific commercial package of 118 ml in 1 bottle, pump of Methyl Salicylate 25%, a human over the counter drug labeled by Oncora Pharma, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 118 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 Oncora Pharma, Llc on June 11, 2025. The current certification is valid through December 31, 2026.

How is this Oncora Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85477030110. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
85477-301-10
11-Digit CMS (5-4-2)
85477-0301-10

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