Sinsinpap Cool Patch
NDC Package 55264-012-05

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

Package Information

Sinsinpap Cool (levomenthol, thymol, camphor, mentha, eucalyptus) patches is adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.Children under 12 years of age: do not use, consult a doctorFor easy application: partially peel back protective film and apply exposed patch to the site of pain.Carefully remove remaining film while pressing patch to skin for secure adhesion. This formulation utilizes a patch delivery system. Marketed by Sinsin Pharmaceutical Co., Ltd., this product is identified by NDC 55264-012 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
55264-012-05
Package Description
1 POUCH in 1 CARTON / 5 PATCH in 1 POUCH (55264-012-04)
Product Code
55264-012
11-Digit Billing Format
55264001205
RxNorm Crosswalk
  • RxCUI: 1795944 - camphor 82.4 MG / eucalyptus oil 16.5 MG / levomenthol 49.4 MG / peppermint oil 164.7 MG / thymol 16.5 MG Medicated Patch
  • RxCUI: 1795944 - camphor 82.4 MG / Eucalyptus oil 16.5 MG / levomenthol 49.4 MG / peppermint oil 164.7 MG / thymol 16.5 MG Medicated Patch

Clinical Specifications

Proprietary Name
Sinsinpap Cool
Non-Proprietary Name
Levomenthol, Thymol, Camphor, Mentha, Eucalyptus
Substance Name
Camphor (synthetic); Eucalyptus Oil; Levomenthol; Peppermint Oil; Thymol
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: apply to affected area not more than 3 to 4 times daily.Children under 12 years of age: do not use, consult a doctorFor easy application: partially peel back protective film and apply exposed patch to the site of pain.Carefully remove remaining film while pressing patch to skin for secure adhesion.

Regulatory & Marketing

Labeler Name
Sinsin Pharmaceutical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-30-2016
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 55264-012-05 identifies a specific commercial package of 1 pouch in 1 carton / 5 patch in 1 pouch (55264-012-04) of Sinsinpap Cool, 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); eucalyptus oil; levomenthol; peppermint oil; thymol 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 May 30, 2016. 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: 55264001205. 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)
55264-012-05
11-Digit CMS (5-4-2)
55264-0012-05

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