Dona
NDC Package 83658-009-01

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.

Dona is dry skin before use. Marketed by Sj Incorporation Ltd, this product is identified by NDC 83658-009.

Identification & Billing

NDC Package Code
83658-009-01
Package Description
5 mg in 1 PACKAGE
Product Code
83658-009
11-Digit Billing Format
83658000901
RxNorm Crosswalk
  • RxCUI: 2670206 - eucalyptus oil 5 % / menthol 10 % Medicated Patch
  • RxCUI: 2670206 - Eucalyptus oil 0.05 MG/MG / menthol 0.1 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Dona
Dosage Form
-
Usage Information
Dry skin before use. Cut open the foil sachet, remove a patch and peel off the protective paper from the central cut. Tip: Be careful when peeling the protective paper as the patch can stick to itself.Apply adhesive side of the patch where you want the cooling effect.Remove gently using warm water to loosen the adhesive. Discard and replace with a new patch as required.

Regulatory & Marketing

Labeler Name
Sj Incorporation Ltd
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-20-2023
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 83658-009-01 identifies a specific commercial package of 5 mg in 1 package of Dona, labeled by Sj Incorporation Ltd. 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 Sj Incorporation Ltd on November 20, 2023. The current certification is valid through December 31, 2024.

How is this Sj Incorporation Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83658000901. 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)
83658-009-01
11-Digit CMS (5-4-2)
83658-0009-01

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