X-treme Freeze Gel
NDC Package 67777-144-40

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

X-treme Freeze (cold therapy gel) gel is adults and children 2 years of age or older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult physician. This formulation utilizes a gel delivery system. Marketed by Dynarex Corporation, this product is identified by NDC 67777-144 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
67777-144-40
Package Description
12 BOTTLE, PUMP in 1 CASE / 473 mL in 1 BOTTLE, PUMP (67777-144-41)
Product Code
67777-144
11-Digit Billing Format
67777014440
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
X-treme Freeze
Non-Proprietary Name
Cold Therapy Gel
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 4 g/100mL
Usage Information
Adults and children 2 years of age or older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult physician

Regulatory & Marketing

Labeler Name
Dynarex Corporation
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-17-2018
Listing Expiration
12-31-2027
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 (67777-144). Click a package code to view its specific billing and regulatory data.

67777-144-10
200 BOX in 1 CASE / 100 PACKET in 1 BOX (67777-144-11) / 3 mL in 1 PACKET
67777-144-20
24 TUBE in 1 CASE / 118 mL in 1 TUBE (67777-144-21)
67777-144-70
2 BOTTLE, PLASTIC in 1 CASE / 3785 mL in 1 BOTTLE, PLASTIC (67777-144-71)

* 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 67777-144-40 identifies a specific commercial package of 12 bottle, pump in 1 case / 473 ml in 1 bottle, pump (67777-144-41) of X-treme Freeze, a human over the counter drug labeled by Dynarex Corporation. 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 Dynarex Corporation on August 17, 2018. The current certification is valid through December 31, 2027.

How is this Dynarex Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67777014440. 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)
67777-144-40
11-Digit CMS (5-4-2)
67777-0144-40

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