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  5. NDC Package Code: 82168-001-01 Coffe Tea Stain Remover Tooth

NDC Package 82168-001-01 Coffe Tea Stain Remover Tooth

Coffe Tea Stain Remover Toothpaste Paste 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:
82168-001-01
Package Description:
150 g in 1 TUBE
Product Code:
82168-001
Proprietary Name:
Coffe Tea Stain Remover Tooth
Non-Proprietary Name:
Coffe Tea Stain Remover Toothpaste
Substance Name:
Sodium Monofluorophosphate
Usage Information:
Adults and children 2 years of age & older: Brush teth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision,Children under 2 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
82168000101
NDC to RxNorm Crosswalk:
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste
Product Type:
Human Otc Drug
Labeler Name:
Guangzhou City Caiye Cosmetics Co., Ltd
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):
Dental - Administration to a tooth or teeth.
Active Ingredient(s):
SODIUM MONOFLUOROPHOSPHATE .76 g/100g
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
11-29-2024
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 82168-001-01?

The NDC Packaged Code 82168-001-01 is assigned to a package of 150 g in 1 tube of Coffe Tea Stain Remover Tooth, a human over the counter drug labeled by Guangzhou City Caiye Cosmetics Co., Ltd. The product's dosage form is paste and is administered via dental form.

Is NDC 82168-001 included in the NDC Directory?

Yes, Coffe Tea Stain Remover Tooth with product code 82168-001 is active and included in the NDC Directory. The product was first marketed by Guangzhou City Caiye Cosmetics Co., Ltd on November 29, 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 82168-001-01?

The 11-digit format is 82168000101. 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
5-3-282168-001-015-4-282168-0001-01