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  5. NDC Package Code: 55346-0408-1 Home Care Fluoride

NDC Package 55346-0408-1 Home Care Fluoride

Stannous Fluoride Gel Dental; Oral - 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:
55346-0408-1
Package Description:
121.9 g in 1 TUBE
Product Code:
55346-0408
Proprietary Name:
Home Care Fluoride
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 6 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
55346040801
Product Type:
Human Otc Drug
Labeler Name:
Dental Technologies, Inc.
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s):
  • Dental - Administration to a tooth or teeth.
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE .969 mg/g
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    12-31-1999
    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 55346-0408-1?

    The NDC Packaged Code 55346-0408-1 is assigned to a package of 121.9 g in 1 tube of Home Care Fluoride, a human over the counter drug labeled by Dental Technologies, Inc.. The product's dosage form is gel and is administered via dental; oral form.

    Is NDC 55346-0408 included in the NDC Directory?

    Yes, Home Care Fluoride with product code 55346-0408 is active and included in the NDC Directory. The product was first marketed by Dental Technologies, Inc. on December 31, 1999 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 55346-0408-1?

    The 11-digit format is 55346040801. 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
    5-4-155346-0408-15-4-255346-0408-01