Amerfresh Toothpowder
NDC Package 85162-007-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Amerfresh Toothpowder (sodium fluoride) powders is 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. This formulation utilizes a powder delivery system. Marketed by Yangzhou One & Only Personal Care Products Co., Ltd, this product is identified by NDC 85162-007 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
85162-007-01
Package Description
40 PACKAGE in 1 CARTON / 454 g in 1 PACKAGE
Product Code
85162-007
11-Digit Billing Format
85162000701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amerfresh Toothpowder
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
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
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
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.

Regulatory & Marketing

Labeler Name
Yangzhou One & Only Personal Care Products Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-13-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (85162-007). Click a package code to view its specific billing and regulatory data.

85162-007-02
4 BOX in 1 CARTON / 50 POUCH in 1 BOX / 57 g in 1 POUCH

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 85162-007-01 identifies a specific commercial 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. This powder is formulated for topical use and contains sodium fluoride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Yangzhou One & Only Personal Care Products Co., Ltd on August 13, 2025. The current certification is valid through December 31, 2027.

How is this Yangzhou One & Only Personal Care Products Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85162000701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
85162-007-01
11-Digit CMS (5-4-2)
85162-0007-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.