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  5. NDC Package Code: 36800-201-19 Sensitive Whitening Anticavity

NDC Package 36800-201-19 Sensitive Whitening Anticavity

Stannous Flouride 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:
36800-201-19
Package Description:
1 TUBE in 1 CARTON / 113 g in 1 TUBE
Product Code:
36800-201
Proprietary Name:
Sensitive Whitening Anticavity
Non-Proprietary Name:
Stannous Flouride
Substance Name:
Stannous Fluoride
Usage Information:
Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush brush teeth thoroughly for at least one minute twise a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.children under 12 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
36800020119
NDC to RxNorm Crosswalk:
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco
    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):
  • STANNOUS FLUORIDE .15 g/100g
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-31-2019
    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 36800-201-19?

    The NDC Packaged Code 36800-201-19 is assigned to a package of 1 tube in 1 carton / 113 g in 1 tube of Sensitive Whitening Anticavity, a human over the counter drug labeled by Topco. The product's dosage form is paste, dentifrice and is administered via dental form.

    Is NDC 36800-201 included in the NDC Directory?

    Yes, Sensitive Whitening Anticavity with product code 36800-201 is active and included in the NDC Directory. The product was first marketed by Topco on October 31, 2019 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 36800-201-19?

    The 11-digit format is 36800020119. 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
    5-3-236800-201-195-4-236800-0201-19