Biofreeze Foot Pain Relief Set Kit
NDC Package 59316-002-10

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

Package Information

Biofreeze Foot Pain Relief Set (menthol) kits is • Adults and Children 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary • Children under 12 years of age: Consult physician. This formulation utilizes a kit delivery system. Marketed by Reckitt Benckiser Llc, this product is identified by NDC 59316-002 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
59316-002-10
Package Description
1 KIT in 1 KIT * 85 g in 1 TUBE (59316-001-10)
Product Code
59316-002
11-Digit Billing Format
59316000210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Biofreeze Foot Pain Relief Set
Non-Proprietary Name
Menthol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
• Adults and Children 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary • Children under 12 years of age: Consult physician

Regulatory & Marketing

Labeler Name
Reckitt Benckiser Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-12-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59316-002-10 identifies a specific commercial package of 1 kit in 1 kit * 85 g in 1 tube (59316-001-10) of Biofreeze Foot Pain Relief Set, a human over the counter drug labeled by Reckitt Benckiser Llc. This kit is formulated for use and contains 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 March 12, 2021. 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: 59316000210. 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)
59316-002-10
11-Digit CMS (5-4-2)
59316-0002-10

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