Zohar Anti Cavity Mouthwash Fresh Mint Flavour Liquid
NDC Package 84045-003-00

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

Package Information

Zohar Anti Cavity Mouthwash Fresh Mint Flavour (sodium fluoride) liquids is adults and children 6 years of age and older:use once a day after brushing your teeth with a toothpaste vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit outdo not swallow the rinse do not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary untill capable of using without supervision.Children under 6 years of age:consult a dentist or doctor. This formulation utilizes a liquid delivery system. Marketed by Zohar Kosher Limited, this product is identified by NDC 84045-003 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84045-003-00
Package Description
500 mL in 1 BOTTLE
Product Code
84045-003
11-Digit Billing Format
84045000300
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zohar Anti Cavity Mouthwash Fresh Mint Flavour
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 .2 mg/mL
Usage Information
Adults and children 6 years of age and older:use once a day after brushing your teeth with a toothpaste vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit outdo not swallow the rinse do not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary untill capable of using without supervision.Children under 6 years of age:consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Zohar Kosher Limited
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-15-2024
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 84045-003-00 identifies a specific commercial package of 500 ml in 1 bottle of Zohar Anti Cavity Mouthwash Fresh Mint Flavour, a human over the counter drug labeled by Zohar Kosher Limited. 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 Zohar Kosher Limited on March 15, 2024. The current certification is valid through December 31, 2026.

How is this Zohar Kosher Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84045000300. 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)
84045-003-00
11-Digit CMS (5-4-2)
84045-0003-00

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