Biofreeze Precision Relief Pen Liquid
NDC Package 59316-830-38

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 Precision Relief Pen (menthol) liquids is • Adults and Children 12 years of age and older: Press pen straight down onto affected area and hold until tip is fully soaked with liquid. This formulation utilizes a liquid delivery system. Marketed by Reckitt Benckiser Llc, this product is identified by NDC 59316-830 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
59316-830-38
Package Description
1 BOTTLE in 1 CARTON / 34 mL in 1 BOTTLE
Product Code
59316-830
11-Digit Billing Format
59316083038
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Biofreeze Precision Relief Pen
Non-Proprietary Name
Menthol
Substance Name
Menthol, Unspecified Form
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 105 mg/mL
Usage Information
• Adults and Children 12 years of age and older: Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto affected area and let dry. Repeat use 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
12-31-2020
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 (59316-830). Click a package code to view its specific billing and regulatory data.

59316-830-37
34 mL in 1 BOTTLE

* 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 59316-830-38 identifies a specific commercial package of 1 bottle in 1 carton / 34 ml in 1 bottle of Biofreeze Precision Relief Pen, a human over the counter drug labeled by Reckitt Benckiser Llc. This liquid 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 December 31, 2020. 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: 59316083038. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
59316-830-38
11-Digit CMS (5-4-2)
59316-0830-38

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