Oral Defense Fluoride Rinse
NDC Package 52644-002-00

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

Package Information

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

Oral Defense Fluoride Rinse is adults and children 6 years of age and olderUse once a day, preferably before bedtime, after brushing and flossing thoroughly.For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Marketed by Oral Defense, Llc, this product is identified by NDC 52644-002 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
52644-002-00
Package Description
474 mL in 1 BOTTLE, PLASTIC
Product Code
52644-002
11-Digit Billing Format
52644000200
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oral Defense Fluoride Rinse
Dosage Form
-
Usage Information
Adults and children 6 years of age and olderUse once a day, preferably before bedtime, after brushing and flossing thoroughly.For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow.Supervise children over 6 years of age until capable of suing without supervision.Consult with a dentist or doctor for use with children under 6 years of age.Do not take in food or drink for 30 minutes after application.

Regulatory & Marketing

Labeler Name
Oral Defense, Llc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-31-2010
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52644-002). Click a package code to view its specific billing and regulatory data.

52644-002-02
60 mL in 1 BOTTLE, PLASTIC

* 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 52644-002-00 identifies a specific commercial package of 474 ml in 1 bottle, plastic of Oral Defense Fluoride Rinse, labeled by Oral Defense, Llc. 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 Oral Defense, Llc on August 31, 2010. The current certification is valid through December 31, 2017.

How is this Oral Defense, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52644000200. 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)
52644-002-00
11-Digit CMS (5-4-2)
52644-0002-00

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