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  5. NDC Package Code: 59316-004-04 Biofreeze Flexible Relief Strip

NDC Package 59316-004-04 Biofreeze Flexible Relief Strip

Menthol Patch Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
59316-004-04
Package Description:
4 PATCH in 1 CARTON / 6 g in 1 PATCH
Product Code:
59316-004
Proprietary Name:
Biofreeze Flexible Relief Strip
Non-Proprietary Name:
Menthol
Substance Name:
Menthol, Unspecified Form
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
11-Digit NDC Billing Format:
59316000404
NDC to RxNorm Crosswalk:
  • RxCUI: 2566836 - menthol 5.6 % Medicated Patch
  • RxCUI: 2566836 - menthol 0.056 MG/MG Medicated Patch
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rb Health (us) Llc
    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(s):
  • 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
    • Sample Package:
    No
    FDA Application Number:
    part348
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    03-31-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    59316-004-011 PATCH in 1 POUCH / 6 g in 1 PATCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59316-004-04?

    The NDC Packaged Code 59316-004-04 is assigned to a package of 4 patch in 1 carton / 6 g in 1 patch of Biofreeze Flexible Relief Strip, a human over the counter drug labeled by Rb Health (us) Llc. The product's dosage form is patch and is administered via topical form.

    Is NDC 59316-004 included in the NDC Directory?

    Yes, Biofreeze Flexible Relief Strip with product code 59316-004 is active and included in the NDC Directory. The product was first marketed by Rb Health (us) Llc on March 31, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 59316-004-04?

    The 11-digit format is 59316000404. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-259316-004-045-4-259316-0004-04