Cold And Hot Medicated Large Patch
NDC Package 52000-421-41

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

Cold And Hot Medicated Large (menthol) patches is adults and Children 12 years of age and older:• Peel off protective backing and apply sticky side to affected area. This formulation utilizes a patch delivery system. Marketed by Universal Distribution Center Llc, this product is identified by NDC 52000-421 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
52000-421-41
Package Description
1 PATCH in 1 POUCH / 19 g in 1 PATCH
Product Code
52000-421
11-Digit Billing Format
52000042141
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cold And Hot Medicated Large
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 .05 g/g
Usage Information
Adults and Children 12 years of age and older:• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch• Should be used up to 8 hours• Should be used no more than 3 to 4 times dailyChildren under 12 years of age: Consult a doctor.

Regulatory & Marketing

Labeler Name
Universal Distribution Center Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-25-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52000-421). Click a package code to view its specific billing and regulatory data.

52000-421-42
24 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 19 g in 1 PATCH

* 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 52000-421-41 identifies a specific commercial package of 1 patch in 1 pouch / 19 g in 1 patch of Cold And Hot Medicated Large, a human over the counter drug labeled by Universal Distribution Center Llc. 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 Universal Distribution Center Llc on November 25, 2024. The current certification is valid through December 31, 2026.

How is this Universal Distribution Center Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52000042141. 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)
52000-421-41
11-Digit CMS (5-4-2)
52000-0421-41

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