Topcare Cold And Hot Medicated Patch
NDC Package 36800-860-05

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

Package Information

Topcare Cold And Hot Medicated (menthol) patches is directionsopen pouch and remove patchcarefully peel off protective backing and apply sticky side to affected areaadults and children 12 years of age and older:do not wear patch for more than 8 hoursapply to affected area no more than 3 times dailychildren under 12 years of age: consult a doctor. This formulation utilizes a patch delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-860 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
36800-860-05
Package Description
5 PATCH in 1 BOX / 1 PATCH in 1 PATCH
Product Code
36800-860
11-Digit Billing Format
36800086005
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topcare Cold And Hot Medicated
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 50 mg/1
Usage Information
Directionsopen pouch and remove patchcarefully peel off protective backing and apply sticky side to affected areaadults and children 12 years of age and older:do not wear patch for more than 8 hoursapply to affected area no more than 3 times dailychildren under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-23-2019
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 36800-860-05 identifies a specific commercial package of 5 patch in 1 box / 1 patch in 1 patch of Topcare Cold And Hot Medicated, a human over the counter drug labeled by Topco Associates Llc. 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 Topco Associates Llc on April 23, 2019. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800086005. 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)
36800-860-05
11-Digit CMS (5-4-2)
36800-0860-05

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