Cvs Health Cooling Patch
NDC Package 51316-976-10

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

Package Information

Cvs Health Cooling Patch (menthol) patches is adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. This formulation utilizes a patch delivery system. Marketed by Cvs Pharmacy, Inc, this product is identified by NDC 51316-976 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
51316-976-10
Package Description
10 PATCH in 1 CARTON / 9 g in 1 PATCH
Product Code
51316-976
11-Digit Billing Format
51316097610
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cvs Health Cooling Patch
Non-Proprietary Name
Menthol
Substance Name
Menthol
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 5 g/100g
Usage Information
Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch up to 8 hours period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Cvs Pharmacy, Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2024
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 51316-976-10 identifies a specific commercial package of 10 patch in 1 carton / 9 g in 1 patch of Cvs Health Cooling Patch, a human over the counter drug labeled by Cvs Pharmacy, Inc. This patch is formulated for topical use and contains menthol 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 Cvs Pharmacy, Inc on September 01, 2024. The current certification is valid through December 31, 2026.

How is this Cvs Pharmacy, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316097610. 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)
51316-976-10
11-Digit CMS (5-4-2)
51316-0976-10

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