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  5. NDC Package Code: 0135-0558-01 Biotene Gentle Mint

NDC Package 0135-0558-01 Biotene Gentle Mint

Sodium Fluoride Paste 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:
0135-0558-01
Package Description:
1 TUBE in 1 CARTON / 121.9 g in 1 TUBE
Product Code:
0135-0558
Proprietary Name:
Biotene Gentle Mint
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Adults and children over 12 years•apply toothpaste onto a soft bristle toothbrush•brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.
11-Digit NDC Billing Format:
00135055801
NDC to RxNorm Crosswalk:
  • RxCUI: 1044547 - sodium fluoride 0.25 % Toothpaste
  • RxCUI: 1044547 - sodium fluoride 0.0025 MG/MG Toothpaste
  • RxCUI: 1044547 - sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.24 % Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.0024 MG/MG Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    Dosage Form:
    Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE 1.5 mg/g
    • Sample Package:
    No
    FDA Application Number:
    M022
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    07-15-2013
    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 0135-0558-01?

    The NDC Packaged Code 0135-0558-01 is assigned to a package of 1 tube in 1 carton / 121.9 g in 1 tube of Biotene Gentle Mint, a human over the counter drug labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is paste and is administered via oral form.

    Is NDC 0135-0558 included in the NDC Directory?

    Yes, Biotene Gentle Mint with product code 0135-0558 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc on July 15, 2013 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 0135-0558-01?

    The 11-digit format is 00135055801. 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 4-4-2 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
    4-4-20135-0558-015-4-200135-0558-01