Denti-care Denti-rinse Liquid
NDC Package 64778-0446-3

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

Package Information

Denti-care Denti-rinse (sodium fluoride) liquids is indications: Topical anti-carie solution. This formulation utilizes a liquid delivery system. Marketed by Amd Medicom, this product is identified by NDC 64778-0446.

Identification & Billing

NDC Package Code
64778-0446-3
Package Description
12 BOTTLE, PUMP in 1 CASE / 1900 mL in 1 BOTTLE, PUMP (64778-0446-1)
Product Code
64778-0446
11-Digit Billing Format
64778044603
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .02 g/mL
Usage Information
Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations. Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit, repeat the rinse procedure with an additional 10mL. Advise patient not to eat, drink or rinse for 30 minutes after application.Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls

Regulatory & Marketing

Labeler Name
Amd Medicom
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
03-01-2001
End Marketing Date
05-31-2027
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 64778-0446-3 identifies a specific commercial package of 12 bottle, pump in 1 case / 1900 ml in 1 bottle, pump (64778-0446-1) of Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse, a human prescription drug labeled by Amd Medicom. This liquid is formulated for dental 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 Amd Medicom on March 01, 2001.

How is this Amd Medicom product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64778044603. 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 (5-4-1)
64778-0446-3
11-Digit CMS (5-4-2)
64778-0446-03

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