Optimax Purple Anticavity Fluoride Kit
NDC Package 73656-034-00

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

Package Information

Optimax Purple Anticavity Fluoride (sodium monofluorophosphate) kits is  Adults and children 2 years of age & older:  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). This formulation utilizes a kit delivery system. Marketed by White Glo Usa Inc, this product is identified by NDC 73656-034 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
73656-034-00
Package Description
1 KIT in 1 KIT * 2 TUBE in 1 BOX (73656-035-00) / 150 g in 1 TUBE
Product Code
73656-034
11-Digit Billing Format
73656003400
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Optimax Purple Anticavity Fluoride
Non-Proprietary Name
Sodium Monofluorophosphate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
 Adults and children 2 years of age & older:  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
White Glo Usa Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-31-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73656-034-00 identifies a specific commercial package of 1 kit in 1 kit * 2 tube in 1 box (73656-035-00) / 150 g in 1 tube of Optimax Purple Anticavity Fluoride, a human over the counter drug labeled by White Glo Usa Inc. 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 White Glo Usa Inc on March 31, 2025. The current certification is valid through December 31, 2026.

How is this White Glo Usa Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73656003400. 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)
73656-034-00
11-Digit CMS (5-4-2)
73656-0034-00

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