Profoot Plantar Relief Strips Patch
NDC Package 29784-602-01

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

Package Information

Profoot Plantar Relief Strips (camphor (natural), menthol, methyl salicylate) patches is adults and children 12 years of age and over:• clean and dry affected area • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • apply to affected area not more than 3-4 times daily • remove patch from skin after at most 8 hoursChildren under 12 years of age:consult a doctor . This formulation utilizes a patch delivery system. Marketed by Rooftop Consumer Health, Inc., this product is identified by NDC 29784-602 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
29784-602-01
Package Description
1 POUCH in 1 BOX / 4 PATCH in 1 POUCH / 1.03 g in 1 PATCH
Product Code
29784-602
11-Digit Billing Format
29784060201
RxNorm Crosswalk
  • RxCUI: 853260 - camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated Patch
  • RxCUI: 853260 - camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Profoot Plantar Relief Strips
Non-Proprietary Name
Camphor (natural), Menthol, Methyl Salicylate
Substance Name
Camphor (natural); 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
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 12 years of age and over:• clean and dry affected area • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • apply to affected area not more than 3-4 times daily • remove patch from skin after at most 8 hoursChildren under 12 years of age:consult a doctor 

Regulatory & Marketing

Labeler Name
Rooftop Consumer Health, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-18-2023
End Marketing Date
05-31-2027
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 29784-602-01 identifies a specific commercial package of 1 pouch in 1 box / 4 patch in 1 pouch / 1.03 g in 1 patch of Profoot Plantar Relief Strips, a human over the counter drug labeled by Rooftop Consumer Health, Inc.. This patch is formulated for topical use and contains camphor (natural); 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 Rooftop Consumer Health, Inc. on October 18, 2023.

How is this Rooftop Consumer Health, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 29784060201. 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)
29784-602-01
11-Digit CMS (5-4-2)
29784-0602-01

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