Amerfresh Fluoride Paste, Dentifrice
NDC Package 85162-002-07

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 Fluoride (sodium fluoride) pastes is do not swallowsupervise 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 paste, dentifrice delivery system. Marketed by Yangzhou One & Only Personal Care Products Co., Ltd, this product is identified by NDC 85162-002 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
85162-002-07
Package Description
1000 POUCH in 1 BOX / 7 g in 1 POUCH
Product Code
85162-002
11-Digit Billing Format
85162000207
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amerfresh Fluoride
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
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
Do not swallowsupervise 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
01-16-2025
Listing Expiration
12-31-2026
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 (85162-002). Click a package code to view its specific billing and regulatory data.

85162-002-01
144 TUBE in 1 BOX / 17 g in 1 TUBE
85162-002-02
144 TUBE in 1 BOX / 24 g in 1 TUBE
85162-002-03
144 TUBE in 1 BOX / 43 g in 1 TUBE
85162-002-04
144 TUBE in 1 BOX / 78 g in 1 TUBE
85162-002-05
144 TUBE in 1 BOX / 85 g in 1 TUBE
85162-002-06
144 TUBE in 1 BOX / 142 g in 1 TUBE

* 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 85162-002-07 identifies a specific commercial package of 1000 pouch in 1 box / 7 g in 1 pouch of Amerfresh Fluoride, a human over the counter drug labeled by Yangzhou One & Only Personal Care Products Co., Ltd. This paste, dentifrice 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 January 16, 2025. The current certification is valid through December 31, 2026.

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: 85162000207. 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)
85162-002-07
11-Digit CMS (5-4-2)
85162-0002-07

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