Zims Max Freeze Patch
NDC Package 54273-012-01

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

Package Information

Zims Max Freeze (lidocaine hydrochloride and menthol,) patches is adults and children 12 years of age and over:clean and dry affected arearemove film from patch and apply to the skin (see illustration)apply 1 patch at a time to affected area, not more than 3 to 4 times dailyChildren under 12 years of age:consult a doctor. This formulation utilizes a patch delivery system. Marketed by Kobayashi Healthcare International, Inc., this product is identified by NDC 54273-012 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
54273-012-01
Package Description
3 POUCH in 1 BOX / 1 PATCH in 1 POUCH
Product Code
54273-012
11-Digit Billing Format
54273001201
RxNorm Crosswalk
  • RxCUI: 1373130 - lidocaine HCl 4 % / menthol 1 % Medicated Patch
  • RxCUI: 1373130 - lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Zims Max Freeze
Non-Proprietary Name
Lidocaine Hydrochloride And Menthol,
Substance Name
Lidocaine Hydrochloride; 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)
Pharmacologic Class
Usage Information
Adults and children 12 years of age and over:clean and dry affected arearemove film from patch and apply to the skin (see illustration)apply 1 patch at a time to affected area, not more than 3 to 4 times dailyChildren under 12 years of age:consult a doctor

Regulatory & Marketing

Labeler Name
Kobayashi Healthcare International, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-10-2023
Listing Expiration
12-31-2026
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 54273-012-01 identifies a specific commercial package of 3 pouch in 1 box / 1 patch in 1 pouch of Zims Max Freeze, a human over the counter drug labeled by Kobayashi Healthcare International, Inc.. This patch is formulated for topical use and contains lidocaine hydrochloride; 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 Kobayashi Healthcare International, Inc. on May 10, 2023. The current certification is valid through December 31, 2026.

How is this Kobayashi Healthcare International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54273001201. 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)
54273-012-01
11-Digit CMS (5-4-2)
54273-0012-01

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