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  5. NDC Package Code: 61543-1502-3 Plus White Extra Whitening

NDC Package 61543-1502-3 Plus White Extra Whitening

Sodium Monofluorophosphate Paste, Dentifrice 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:
61543-1502-3
Package Description:
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code:
61543-1502
Proprietary Name:
Plus White Extra Whitening
Non-Proprietary Name:
Sodium Monofluorophosphate
Substance Name:
Sodium Monofluorophosphate
Usage Information:
Adults and children 2 years and olderBrush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physicianto minimize swallowing for children under the age of 6, use a pea size amountandsupervisebrushinguntil good habitsare establishedchildren under 2 years of ask a dentistor physician
11-Digit NDC Billing Format:
61543150203
NDC to RxNorm Crosswalk:
  • RxCUI: 1247591 - sodium monofluorophosphate 0.83 % (fluoride 0.11 % ) Toothpaste
  • RxCUI: 1247591 - sodium monofluorophosphate 0.0083 MG/MG Toothpaste
  • RxCUI: 1247591 - sodium monofluorophosphate 0.83 % Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cca Industries Llc
    Dosage Form:
    Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM MONOFLUOROPHOSPHATE .83 g/100g
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    01-31-2018
    Listing Expiration Date:
    12-31-2024
    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 61543-1502-3?

    The NDC Packaged Code 61543-1502-3 is assigned to a package of 1 tube in 1 carton / 100 g in 1 tube of Plus White Extra Whitening, a human over the counter drug labeled by Cca Industries Llc. The product's dosage form is paste, dentifrice and is administered via dental form.

    Is NDC 61543-1502 included in the NDC Directory?

    Yes, Plus White Extra Whitening with product code 61543-1502 is active and included in the NDC Directory. The product was first marketed by Cca Industries Llc on January 31, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 61543-1502-3?

    The 11-digit format is 61543150203. 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 5-4-1 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
    5-4-161543-1502-35-4-261543-1502-03