Arex Sinsin Pas Patch
NDC Package 55264-021-06

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

Package Information

Arex Sinsin Pas (camphor, mentha oil, menthol, methyl salicylate, zinc oxide) patches is adults and children 12 years of age and over:Clean and dry affected areaRemove patch from film.Apply to affected area not more than 3 to 4 times daily for 7 days.Remove patch from skin after at most 8 hours application.Children under 12 years of age:Consult a doctor. This formulation utilizes a patch delivery system. Marketed by Sinsin Pharmaceutical Co., Ltd., this product is identified by NDC 55264-021 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
55264-021-06
Package Description
1 POUCH in 1 CARTON / 6 PATCH in 1 POUCH
Product Code
55264-021
11-Digit Billing Format
55264002106

Clinical Specifications

Proprietary Name
Arex Sinsin Pas
Non-Proprietary Name
Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide
Substance Name
Camphor (synthetic); Levomenthol; Methyl Salicylate; Peppermint Oil; Zinc Oxide
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
  • Cutaneous - Administration to the skin.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and children 12 years of age and over:Clean and dry affected areaRemove patch from film.Apply to affected area not more than 3 to 4 times daily for 7 days.Remove patch from skin after at most 8 hours application.Children under 12 years of age:Consult a doctor.

Regulatory & Marketing

Labeler Name
Sinsin Pharmaceutical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-26-2013
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 55264-021-06 identifies a specific commercial package of 1 pouch in 1 carton / 6 patch in 1 pouch of Arex Sinsin Pas, a human over the counter drug labeled by Sinsin Pharmaceutical Co., Ltd.. This patch is formulated for cutaneous; topical; transdermal use and contains camphor (synthetic); levomenthol; methyl salicylate; peppermint oil; zinc oxide 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 Sinsin Pharmaceutical Co., Ltd. on July 26, 2013. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55264002106. 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)
55264-021-06
11-Digit CMS (5-4-2)
55264-0021-06

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