Calypxo Pain Relief Cream
NDC Package 80425-0369-1

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

Package Information

Calypxo Pain Relief (methyl salicylate, menthol) cream is for adults apply directly to affected area. This formulation utilizes a cream delivery system. Marketed by Advanced Rx Of Tennessee, Llc, this product is identified by NDC 80425-0369 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
80425-0369-1
Package Description
113 g in 1 BOTTLE
Product Code
80425-0369
11-Digit Billing Format
80425036901
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
113 GM
RxNorm Crosswalk
  • RxCUI: 1486874 - menthol 3 % / methyl salicylate 10 % Topical Cream
  • RxCUI: 1486874 - menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Calypxo Pain Relief
Non-Proprietary Name
Methyl Salicylate, Menthol
Substance Name
Menthol; 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)
Usage Information
For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

Regulatory & Marketing

Labeler Name
Advanced Rx Of Tennessee, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2023
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 80425-0369-1 identifies a specific commercial package of 113 g in 1 bottle of Calypxo Pain Relief, a human over the counter drug labeled by Advanced Rx Of Tennessee, Llc. This product is billed per "GM" gram and contains an estimated amount of 113 billable units per package. This cream is formulated for topical use and contains menthol; 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 Advanced Rx Of Tennessee, Llc on December 01, 2023. The current certification is valid through December 31, 2026.

How is this Advanced Rx Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425036901. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 113 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)
80425-0369-1
11-Digit CMS (5-4-2)
80425-0369-01

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