Satohap Cool And Hot Pads Patch
NDC Package 49873-621-01

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

Package Information

Satohap Cool And Hot Pads (camphor, capsaicin, menthol) patches is adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area. This formulation utilizes a patch delivery system. Marketed by Sato Pharmaceutical Co., Ltd., this product is identified by NDC 49873-621 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
49873-621-01
Package Description
1 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 9.36 g in 1 PATCH
Product Code
49873-621
11-Digit Billing Format
49873062101
RxNorm Crosswalk
  • RxCUI: 2694729 - camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated Patch
  • RxCUI: 2694729 - camphor 0.031 MG/MG / capsaicin 0.00025 MG/MG / menthol 0.06 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Satohap Cool And Hot Pads
Non-Proprietary Name
Camphor, Capsaicin, Menthol
Substance Name
Camphor (synthetic); Capsaicin; Levomenthol
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)
Usage Information
Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area. do not use more than 2 patches per day.Children under 4 years of age: Consult a doctor.

Regulatory & Marketing

Labeler Name
Sato Pharmaceutical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-18-2020
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 49873-621-01 identifies a specific commercial package of 1 pouch in 1 box / 5 patch in 1 pouch / 9.36 g in 1 patch of Satohap Cool And Hot Pads, a human over the counter drug labeled by Sato Pharmaceutical Co., Ltd.. This patch is formulated for topical use and contains camphor (synthetic); capsaicin; levomenthol 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 Sato Pharmaceutical Co., Ltd. on December 18, 2020. The current certification is valid through December 31, 2026.

How is this Sato Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49873062101. 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)
49873-621-01
11-Digit CMS (5-4-2)
49873-0621-01

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