Biofreeze Gel
NDC Package 59316-101-40
Package Information
Biofreeze (menthol) gel is adults and children 2 years of age and 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 Reckitt Benckiser Llc, this product is identified by NDC 59316-101 and is authorized under FDA application M017.
Identification & Billing
- RxCUI: 1043451 - BIOFREEZE 3.5 % Topical Gel
- RxCUI: 1043451 - menthol 0.035 MG/MG Topical Gel [Biofreeze]
- RxCUI: 1043451 - Biofreeze 0.035 MG/MG Topical Gel
- RxCUI: 1043451 - Biofreeze 3.5 % Topical Gel
- RxCUI: 808955 - menthol 3.5 % Topical Gel
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 59316 - Reckitt Benckiser Llc
- 59316-101 - Biofreeze
- 59316-101-40 - 946 mL in 1 BOTTLE, PUMP
- 59316-101 - Biofreeze
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 (59316-101). Click a package code to view its specific billing and regulatory data.
* 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 59316-101-40 identifies a specific commercial package of 946 ml in 1 bottle, pump of Biofreeze, a human over the counter drug labeled by Reckitt Benckiser Llc. 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 Reckitt Benckiser Llc on August 25, 2016. The current certification is valid through December 31, 2027.
How is this Reckitt Benckiser Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 59316010140. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
