Anticavity Fluoride Rinse
NDC Package 36800-004-44

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

Package Information

Anticavity Fluoride Rinse (sodium fluoride) rinses is use aids in the prevention of dental cavities. This formulation utilizes a rinse delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-004 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
36800-004-44
Package Description
532 mL in 1 BOTTLE, PLASTIC
Product Code
36800-004
11-Digit Billing Format
36800000444
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Anticavity Fluoride Rinse
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .2 mg/mL
Usage Information
Use aids in the prevention of dental cavities

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-08-2004
Listing Expiration
12-31-2027
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 36800-004-44 identifies a specific commercial package of 532 ml in 1 bottle, plastic of Anticavity Fluoride Rinse, a human over the counter drug labeled by Topco Associates Llc. This rinse is formulated for oral use and contains sodium fluoride 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 Topco Associates Llc on April 08, 2004. The current certification is valid through December 31, 2027.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800000444. 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)
36800-004-44
11-Digit CMS (5-4-2)
36800-0004-44

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