Rugby Menthol Hot Cold Patch
NDC Package 0536-1332-15

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

Package Information

Rugby Menthol Hot Cold Patch (menthol) patches is directions Adults and children 12 years of age and over:carefully remove backing from patchapply sticky side of patch to affected areawear one patch up to 8 hoursrepeat as necessary, but no more than 3 times dailydiscard patch after single usereseal pouch after opening.Children under 12 years of age: consult a physician. This formulation utilizes a patch delivery system. Marketed by Rugby Laboratories, this product is identified by NDC 0536-1332 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
0536-1332-15
Package Description
5 PATCH in 1 CARTON / 9 g in 1 PATCH
Product Code
0536-1332
11-Digit Billing Format
00536133215
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rugby Menthol Hot Cold Patch
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 5 g/100g
Usage Information
Directions Adults and children 12 years of age and over:carefully remove backing from patchapply sticky side of patch to affected areawear one patch up to 8 hoursrepeat as necessary, but no more than 3 times dailydiscard patch after single usereseal pouch after opening.Children under 12 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Rugby Laboratories
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0536-1332-15 identifies a specific commercial package of 5 patch in 1 carton / 9 g in 1 patch of Rugby Menthol Hot Cold Patch, a human over the counter drug labeled by Rugby Laboratories. 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 Rugby Laboratories on July 01, 2021. The current certification is valid through December 31, 2026.

How is this Rugby Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00536133215. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (4-4-2)
0536-1332-15
11-Digit CMS (5-4-2)
00536-1332-15

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