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  5. NDC Package Code: 83592-801-04 Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor

NDC Package 83592-801-04 Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor

Stannous Fluoride Liquid 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:
83592-801-04
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 118 mL in 1 BOTTLE, GLASS
Product Code:
83592-801
Proprietary Name:
Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
Do not use before mixing with water.Adults and children 6 years of age and older:Use once a day after brushing your teeth with a toothpaste.Open the bottle by twisting the cap counter clockwisePour 1/8 fl. oz. into a cup. Add water to line (1 fl. oz.) on cup.Mix using bristle end of toothbrushVigorously swish rinse between your teeth for 1 min. and then spit out.Do not swallow the rinseDo not eat or drink for 30 min. after rinsing.Instruct children under 12 in good rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision.Children under 6: Consult a dentist or doctor.
11-Digit NDC Billing Format:
83592080104
NDC to RxNorm Crosswalk:
  • RxCUI: 583459 - stannous fluoride 0.63 % Dental Solution
  • RxCUI: 583459 - stannous fluoride 6.3 MG/ML Mouthwash
  • RxCUI: 583459 - stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    True Marker Pharmaceuticals, Inc.
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE .63 mg/100mL
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    04-04-2024
    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 83592-801-04?

    The NDC Packaged Code 83592-801-04 is assigned to a package of 1 bottle, glass in 1 carton / 118 ml in 1 bottle, glass of Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor, a human over the counter drug labeled by True Marker Pharmaceuticals, Inc.. The product's dosage form is liquid and is administered via oral form.

    Is NDC 83592-801 included in the NDC Directory?

    Yes, Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor with product code 83592-801 is active and included in the NDC Directory. The product was first marketed by True Marker Pharmaceuticals, Inc. on April 04, 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 83592-801-04?

    The 11-digit format is 83592080104. 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
    5-3-283592-801-045-4-283592-0801-04