1. Home
  2. Labeler Index
  3. Den-mat Holdings, Llc
  4. 59883-405
  5. NDC Package Code: 59883-405-04 Cleararc

NDC Package 59883-405-04 Cleararc

Stannous Fluoride Gel Gel Topical - 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:
59883-405-04
Package Description:
113.4 g in 1 TUBE
Product Code:
59883-405
Proprietary Name:
Cleararc
Non-Proprietary Name:
Stannous Fluoride Gel
Substance Name:
Stannous Fluoride
Usage Information:
Adults and children 6 years and older: Use once daily after brushing.Apply a thin line of gel to each custom tray. Place firmly over teeth. After wearing trays for 1 minute, remove and spit out any remaining gel. Do not swallow. Do not eat or drink for 30 minutes.Instruct children under 12, in the use of this product (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:
59883040504
NDC to RxNorm Crosswalk:
  • RxCUI: 237847 - stannous fluoride 0.4 % Oral Gel
  • RxCUI: 237847 - stannous fluoride 0.004 MG/MG Oral Gel
  • RxCUI: 237847 - stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Den-mat Holdings, Llc
    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):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE .969 mg/g
    • 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:
    07-07-2022
    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 59883-405-04?

    The NDC Packaged Code 59883-405-04 is assigned to a package of 113.4 g in 1 tube of Cleararc, a human over the counter drug labeled by Den-mat Holdings, Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 59883-405 included in the NDC Directory?

    Yes, Cleararc with product code 59883-405 is active and included in the NDC Directory. The product was first marketed by Den-mat Holdings, Llc on July 07, 2022 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 59883-405-04?

    The 11-digit format is 59883040504. 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
    5-3-259883-405-045-4-259883-0405-04