1. Home
  2. Labeler Index
  3. Yangzhou One & Only Personal Care Products Co., Ltd
  4. 85162-007
  5. NDC Package Code: 85162-007-01 Amerfresh Toothpowder

NDC Package 85162-007-01 Amerfresh Toothpowder

Sodium Fluoride Powder Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
85162-007-01
Package Description:
40 PACKAGE in 1 CARTON / 454 g in 1 PACKAGE
Product Code:
85162-007
Proprietary Name:
Amerfresh Toothpowder
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
For Use:Wet toothbrush and dip into powder until brush is fully covered. Brush teeth and gum line for tleast 30 seconds, rinse and spit out thoroughlydo not swallow .supervise children as necessary until capable of useing without supervisioninstruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children under 6 years of age:do not use unless directed by a doctor or dentist.
11-Digit NDC Billing Format:
85162000701
Product Type:
Human Otc Drug
Labeler Name:
Yangzhou One & Only Personal Care Products Co., Ltd
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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):
SODIUM FLUORIDE .1 g/100g
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
08-13-2025
Listing Expiration Date:
12-31-2026
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
85162-007-024 BOX in 1 CARTON / 50 POUCH in 1 BOX / 57 g in 1 POUCH

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 85162-007-01?

The NDC Packaged Code 85162-007-01 is assigned to a package of 40 package in 1 carton / 454 g in 1 package of Amerfresh Toothpowder, a human over the counter drug labeled by Yangzhou One & Only Personal Care Products Co., Ltd. The product's dosage form is powder and is administered via topical form.

Is NDC 85162-007 included in the NDC Directory?

Yes, Amerfresh Toothpowder with product code 85162-007 is active and included in the NDC Directory. The product was first marketed by Yangzhou One & Only Personal Care Products Co., Ltd on August 13, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85162-007-01?

The 11-digit format is 85162000701. 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
5-3-285162-007-015-4-285162-0007-01