Luminosity Activation Day Edition Kit
NDC Package 83108-100-00

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Luminosity Activation Day Edition (zinc oxide) kits is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a kit delivery system. Marketed by Rationale Group Pty Ltd, this product is identified by NDC 83108-100 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
83108-100-00
Package Description
1 KIT in 1 KIT * 3 mL in 1 BOTTLE (83108-001-13)
Product Code
83108-100
11-Digit Billing Format
83108010000

Clinical Specifications

Proprietary Name
Luminosity Activation Day Edition
Non-Proprietary Name
Zinc Oxide
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Rationale Group Pty Ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-15-2023
End Marketing Date
09-01-2026
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 83108-100-00 identifies a specific commercial package of 1 kit in 1 kit * 3 ml in 1 bottle (83108-001-13) of Luminosity Activation Day Edition, a human over the counter drug labeled by Rationale Group Pty Ltd. This kit is formulated for use and contains 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 Rationale Group Pty Ltd on November 15, 2023.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Rationale Group Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83108010000. 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)
83108-100-00
11-Digit CMS (5-4-2)
83108-0100-00

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