Salonpas Arthritis Pain Patch
NDC Package 46581-680-01

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

Salonpas Arthritis Pain (menthol, methyl salicylate) patches is adults 18 years and older:only use one patch at a timeclean and dry affected arearemove patch from backing film and apply to skin (see illustration)apply one patch to the affected area and leave in place for up to 8 to 12 hoursif pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hoursdo not use more than 2 patches per daydo not use for more than 3 days in a rowthe used patch should be removed from the skin when a new one is appliedChildren under 18 years of age: do not use; this product has not been shown to work in children. This formulation utilizes a patch delivery system. Marketed by Hisamitsu Pharmaceutical Co., Inc., this product is identified by NDC 46581-680 and is authorized under FDA application NDA022029.

Identification & Billing

NDC Package Code
46581-680-01
Package Description
1 PATCH in 1 POUCH
Product Code
46581-680
11-Digit Billing Format
46581068001
RxNorm Crosswalk
  • RxCUI: 853146 - menthol 3 % / methyl salicylate 10 % Medicated Patch
  • RxCUI: 853146 - menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Salonpas Arthritis Pain
Non-Proprietary Name
Menthol, Methyl Salicylate
Substance Name
Menthol; Methyl Salicylate
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
  • Percutaneous - Administration through 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)
Usage Information
Adults 18 years and older:only use one patch at a timeclean and dry affected arearemove patch from backing film and apply to skin (see illustration)apply one patch to the affected area and leave in place for up to 8 to 12 hoursif pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hoursdo not use more than 2 patches per daydo not use for more than 3 days in a rowthe used patch should be removed from the skin when a new one is appliedChildren under 18 years of age: do not use; this product has not been shown to work in children

Regulatory & Marketing

Labeler Name
Hisamitsu Pharmaceutical Co., Inc.
Product Type
Human Otc Drug
FDA Application #
NDA022029
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-25-2008
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 (46581-680). Click a package code to view its specific billing and regulatory data.

46581-680-03
3 PATCH in 1 POUCH
46581-680-05
1 POUCH in 1 BOX / 5 PATCH in 1 POUCH
46581-680-15
3 POUCH in 1 BOX / 5 PATCH in 1 POUCH
46581-680-20
4 POUCH in 1 BOX / 5 PATCH in 1 POUCH
46581-680-99
1 PATCH in 1 POUCH

* 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 46581-680-01 identifies a specific commercial package of 1 patch in 1 pouch of Salonpas Arthritis Pain, a human over the counter drug labeled by Hisamitsu Pharmaceutical Co., Inc.. This patch is formulated for percutaneous; topical; transdermal use and contains menthol; methyl salicylate 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 Hisamitsu Pharmaceutical Co., Inc. on April 25, 2008. The current certification is valid through December 31, 2026.

How is this Hisamitsu Pharmaceutical Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46581068001. 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)
46581-680-01
11-Digit CMS (5-4-2)
46581-0680-01

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