Biofreeze Flexible Relief Strip Patch
NDC Package 59316-004-01

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

Biofreeze Flexible Relief Strip (menthol) patches is adults and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed strip to site of pain. Carefully remove remaining film while pressing the strip to the skin and leave in place for up to 8 hours. This formulation utilizes a patch delivery system. Marketed by Reckitt Benckiser Llc, this product is identified by NDC 59316-004 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
59316-004-01
Package Description
1 PATCH in 1 POUCH / 6 g in 1 PATCH
Product Code
59316-004
11-Digit Billing Format
59316000401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Biofreeze Flexible Relief Strip
Non-Proprietary Name
Menthol
Substance Name
Menthol, Unspecified Form
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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 56 mg/g
Usage Information
Adults and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed strip to site of pain. Carefully remove remaining film while pressing the strip to the skin and leave in place for up to 8 hours. Do not stretch the strip during application as it should be comfortable and not tight. Use on affected areas not more than 4 times daily. For best adhesion: area should be clean, dry, and smooth  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
03-31-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59316-004). Click a package code to view its specific billing and regulatory data.

59316-004-04
4 PATCH in 1 CARTON / 6 g in 1 PATCH

* 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 59316-004-01 identifies a specific commercial package of 1 patch in 1 pouch / 6 g in 1 patch of Biofreeze Flexible Relief Strip, a human over the counter drug labeled by Reckitt Benckiser Llc. This patch 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 March 31, 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: 59316000401. 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)
59316-004-01
11-Digit CMS (5-4-2)
59316-0004-01

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