Cryomax Cooling Gel
NDC Package 71207-461-03

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

Package Information

Cryomax Cooling (menthol) gel is for the temporary relief of minor aches and pains of muscles and joints associated withsimple backachearthritisstrainsbruisessprains. This formulation utilizes a gel delivery system. Marketed by Life Wear Technologies, this product is identified by NDC 71207-461 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
71207-461-03
Package Description
99 g in 1 BOTTLE, PLASTIC
Product Code
71207-461
11-Digit Billing Format
71207046103

Clinical Specifications

Proprietary Name
Cryomax Cooling
Non-Proprietary Name
Menthol
Substance Name
Menthol, (+)-
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
MENTHOL, (+)- 9.5 g/100g
Usage Information
For the temporary relief of minor aches and pains of muscles and joints associated withsimple backachearthritisstrainsbruisessprains

Regulatory & Marketing

Labeler Name
Life Wear Technologies
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2023
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 71207-461-03 identifies a specific commercial package of 99 g in 1 bottle, plastic of Cryomax Cooling, a human over the counter drug labeled by Life Wear Technologies. This gel is formulated for topical use and contains menthol, (+)- 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 Life Wear Technologies on February 01, 2023. The current certification is valid through December 31, 2026.

How is this Life Wear Technologies product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71207046103. 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)
71207-461-03
11-Digit CMS (5-4-2)
71207-0461-03

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