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  5. NDC Package Code: 59316-207-14 Biofreeze Overnight Roll-on

NDC Package 59316-207-14 Biofreeze Overnight Roll-on

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

Table of Contents

    1. Package Information
    2. 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:
59316-207-14
Package Description:
74 mL in 1 BOTTLE
Product Code:
59316-207
Proprietary Name:
Biofreeze Overnight Roll-on
Non-Proprietary Name:
Menthol
Substance Name:
Menthol
Usage Information:
■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily■children under 2 years of age: consult a physician ■wash hands after use with cool water
11-Digit NDC Billing Format:
59316020714
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
74 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1111683 - BIOFREEZE 4 % Topical Gel
  • RxCUI: 1111683 - menthol 0.04 MG/MG Topical Gel [Biofreeze]
  • RxCUI: 1111683 - Biofreeze 0.04 MG/MG Topical Gel
  • RxCUI: 1111683 - Biofreeze 4 % Topical Gel
  • RxCUI: 415974 - menthol 4 % Topical Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rb Health (us) Llc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    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 40 mg/mL
    • 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:
    03-16-2023
    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.

    Frequently Asked Questions

    What is NDC 59316-207-14?

    The NDC Packaged Code 59316-207-14 is assigned to a package of 74 ml in 1 bottle of Biofreeze Overnight Roll-on, a human over the counter drug labeled by Rb Health (us) Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 59316-207 included in the NDC Directory?

    Yes, Biofreeze Overnight Roll-on with product code 59316-207 is active and included in the NDC Directory. The product was first marketed by Rb Health (us) Llc on March 16, 2023 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 NDC billing unit for package 59316-207-14?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 74.

    What is the 11-digit format for NDC 59316-207-14?

    The 11-digit format is 59316020714. 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
    5-3-259316-207-145-4-259316-0207-14