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  5. NDC Package Code: 84045-001-00 Zohar Anti Cavity Mouthwash Coolmint Flavour

NDC Package 84045-001-00 Zohar Anti Cavity Mouthwash Coolmint Flavour

Sodium Fluoride Liquid Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
84045-001-00
Package Description:
500 mL in 1 BOTTLE
Product Code:
84045-001
Proprietary Name:
Zohar Anti Cavity Mouthwash Coolmint Flavour
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
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 (2teaspoonfuls) 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.
11-Digit NDC Billing Format:
84045000100
NDC to RxNorm Crosswalk:
  • RxCUI: 240698 - sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse
  • RxCUI: 240698 - sodium fluoride 0.5 MG/ML Mouthwash
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Zohar Kosher Limited
    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(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .2 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-15-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 84045-001-00?

    The NDC Packaged Code 84045-001-00 is assigned to a package of 500 ml in 1 bottle of Zohar Anti Cavity Mouthwash Coolmint Flavour, a human over the counter drug labeled by Zohar Kosher Limited. The product's dosage form is liquid and is administered via dental form.

    Is NDC 84045-001 included in the NDC Directory?

    Yes, Zohar Anti Cavity Mouthwash Coolmint Flavour with product code 84045-001 is active and included in the NDC Directory. The product was first marketed by Zohar Kosher Limited on March 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 84045-001-00?

    The 11-digit format is 84045000100. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-284045-001-005-4-284045-0001-00