Pro Comfort 8 Hours Patch
NDC Package 83568-4643-5

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pro Comfort 8 Hours Patch is adults and children 12 years of age and older:Wash and dry the affected area.Peel off the backing film from one side of the patch carefully.Apply the exposed portion of the patch to the affected area.Gently press the patch with your hand to fit the affected area completely.Do not exercise vigorously during use to prevent the patch from falling off.Ues only 1 patch for a maximum of 8 hours.children under 12 years of age:Ask a doctor before use. Marketed by Care Living Diagnostics Inc, this product is identified by NDC 83568-4643 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
83568-4643-5
Package Description
5 PATCH in 1 BOX / 4 g in 1 PATCH (83568-4643-1)
Product Code
83568-4643
11-Digit Billing Format
83568464305
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pro Comfort 8 Hours Patch
Dosage Form
-
Usage Information
Adults and children 12 years of age and older:Wash and dry the affected area.Peel off the backing film from one side of the patch carefully.Apply the exposed portion of the patch to the affected area.Gently press the patch with your hand to fit the affected area completely.Do not exercise vigorously during use to prevent the patch from falling off.Ues only 1 patch for a maximum of 8 hours.children under 12 years of age:Ask a doctor before use.

Regulatory & Marketing

Labeler Name
Care Living Diagnostics Inc
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-01-2023
Listing Expiration
12-31-2024
Exclude Flag
I
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 83568-4643-5 identifies a specific commercial package of 5 patch in 1 box / 4 g in 1 patch (83568-4643-1) of Pro Comfort 8 Hours Patch, labeled by Care Living Diagnostics Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Care Living Diagnostics Inc on August 01, 2023. The current certification is valid through December 31, 2024.

How is this Care Living Diagnostics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83568464305. 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 (5-4-1)
83568-4643-5
11-Digit CMS (5-4-2)
83568-4643-05

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