Equate Cool And Heat Patch
NDC Package 49035-888-30

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

Package Information

Equate Cool And Heat (menthol) patches is •adults and children 12 years and over: apply patch to affected area as needed but no more than 4 times daily•children under 12 years: ask a doctor•for easy application: grasp both ends of pad firmly, pull at both ends. This formulation utilizes a patch delivery system. Marketed by Wal-mart Stores Inc, this product is identified by NDC 49035-888 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
49035-888-30
Package Description
1 POUCH in 1 CARTON / 5 PATCH in 1 POUCH
Product Code
49035-888
11-Digit Billing Format
49035088830
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Equate Cool And Heat Extra Strength
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 50 mg/1
Usage Information
•adults and children 12 years and over: apply patch to affected area as needed but no more than 4 times daily•children under 12 years: ask a doctor•for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Regulatory & Marketing

Labeler Name
Wal-mart Stores Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2014
Listing Expiration
12-31-2027
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 49035-888-30 identifies a specific commercial package of 1 pouch in 1 carton / 5 patch in 1 pouch of Equate Cool And Heat Extra Strength, a human over the counter drug labeled by Wal-mart Stores Inc. 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 Wal-mart Stores Inc on July 01, 2014. The current certification is valid through December 31, 2027.

How is this Wal-mart Stores Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035088830. 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)
49035-888-30
11-Digit CMS (5-4-2)
49035-0888-30

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