Icy Hot Patch
NDC Package 62168-0853-2

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

Icy Hot (menthol) patches is adults and children over 12 years:▪remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle▪carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area▪once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area▪wear one Icy Hot patch for up to 8 hours▪repeat as necessary, but no more than 3 times dailychildren 12 years or younger: ask a doctor. This formulation utilizes a patch delivery system. Marketed by Lead Chemical Co., Ltd., this product is identified by NDC 62168-0853 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
62168-0853-2
Package Description
240 POUCH in 1 CARTON / 1 PATCH in 1 POUCH
Product Code
62168-0853
11-Digit Billing Format
62168085302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Icy Hot Medicated, Back
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 428.5 mg/1
Usage Information
Adults and children over 12 years:▪remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle▪carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area▪once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area▪wear one Icy Hot patch for up to 8 hours▪repeat as necessary, but no more than 3 times dailychildren 12 years or younger: ask a doctor

Regulatory & Marketing

Labeler Name
Lead Chemical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-19-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62168-0853). Click a package code to view its specific billing and regulatory data.

62168-0853-1
100 POUCH in 1 CARTON / 5 PATCH in 1 POUCH

* 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 62168-0853-2 identifies a specific commercial package of 240 pouch in 1 carton / 1 patch in 1 pouch of Icy Hot Medicated, Back, a human over the counter drug labeled by Lead Chemical Co., Ltd.. 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 Lead Chemical Co., Ltd. on May 19, 2021. The current certification is valid through December 31, 2026.

How is this Lead Chemical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62168085302. 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 (5-4-1)
62168-0853-2
11-Digit CMS (5-4-2)
62168-0853-02

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