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  5. NDC Package Code: 84045-004-00 Zohar Fluoride Anti Cavity Coolmint Flavour

NDC Package 84045-004-00 Zohar Fluoride Anti Cavity Coolmint Flavour

Sodium Monofluorophosphate Paste 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:
84045-004-00
Package Description:
1 TUBE in 1 CARTON / 113 g in 1 TUBE
Product Code:
84045-004
Proprietary Name:
Zohar Fluoride Anti Cavity Coolmint Flavour
Non-Proprietary Name:
Sodium Monofluorophosphate
Substance Name:
Sodium Monofluorophosphate
Usage Information:
Do not swallowSupervise children as necessary until capable of using without supervision. Adults and children 2 years of age and olderBrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Children under 6 yearsUse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 yearsAsk a dentist or physician
11-Digit NDC Billing Format:
84045000400
NDC to RxNorm Crosswalk:
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Zohar Kosher Limited
    Dosage Form:
    Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g
    • 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 84045-004-00?

    The NDC Packaged Code 84045-004-00 is assigned to a package of 1 tube in 1 carton / 113 g in 1 tube of Zohar Fluoride Anti Cavity Coolmint Flavour, a human over the counter drug labeled by Zohar Kosher Limited. The product's dosage form is paste and is administered via dental form.

    Is NDC 84045-004 included in the NDC Directory?

    Yes, Zohar Fluoride Anti Cavity Coolmint Flavour with product code 84045-004 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 84045-004-00?

    The 11-digit format is 84045000400. 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
    5-3-284045-004-005-4-284045-0004-00