Biofreeze Professional Gel
NDC Package 68071-4325-4

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

Package Information

Biofreeze Professional (menthol, unspecified form) gel is adults and Children 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician. This formulation utilizes a gel delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4325 and is authorized under FDA application M004.

Identification & Billing

NDC Package Code
68071-4325-4
Package Description
120 mL in 1 TUBE
Product Code
68071-4325
11-Digit Billing Format
68071432504
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Biofreeze Professional
Non-Proprietary Name
Menthol, Unspecified Form
Substance Name
Menthol, Unspecified Form
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, UNSPECIFIED FORM 50 mg/mL
Usage Information
Adults and Children 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
Product Type
Human Otc Drug
FDA Application #
M004
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-03-2016
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 68071-4325-4 identifies a specific commercial package of 120 ml in 1 tube of Biofreeze Professional, a human over the counter drug labeled by Nucare Pharmaceuticals,inc.. This gel is formulated for topical use and contains menthol, unspecified form 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 Nucare Pharmaceuticals,inc. on June 03, 2016. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071432504. 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)
68071-4325-4
11-Digit CMS (5-4-2)
68071-4325-04

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