Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth Paste, Dentifrice
NDC Package 85162-003-07

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

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth (sodium fluoride) pastes is adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physicianDo not swallowTo minimize wallowing, use a pea sizes amount in children under 6 yearsSupervise children's brushing until good habits are establishedChildren under 2 years of age: consult a dentist or physician. This formulation utilizes a paste, dentifrice delivery system. Marketed by Yangzhou One & Only Personal Care Products Co., Ltd, this product is identified by NDC 85162-003 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
85162-003-07
Package Description
72 TUBE in 1 BOX / 120 g in 1 TUBE
Product Code
85162-003
11-Digit Billing Format
85162000307
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .1 g/100g
Usage Information
Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physicianDo not swallowTo minimize wallowing, use a pea sizes amount in children under 6 yearsSupervise children's brushing until good habits are establishedChildren under 2 years of age: consult a dentist or physician

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 (85162-003). Click a package code to view its specific billing and regulatory data.

85162-003-01
144 TUBE in 1 BOX / 24 g in 1 TUBE
85162-003-02
5 BOX in 1 CARTON / 24 TUBE in 1 BOX / 28 g in 1 TUBE
85162-003-03
144 TUBE in 1 BOX / 50 g in 1 TUBE
85162-003-04
72 TUBE in 1 BOX / 100 g in 1 TUBE
85162-003-05
144 TUBE in 1 BOX / 100 g in 1 TUBE
85162-003-06
480 TUBE in 1 BOX / 28 g in 1 TUBE
85162-003-08
144 TUBE in 1 BOX / 120 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 85162-003-07 identifies a specific commercial package of 72 tube in 1 box / 120 g in 1 tube of Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth, a human over the counter drug labeled by Yangzhou One & Only Personal Care Products Co., Ltd. This paste, dentifrice is formulated for dental 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: 85162000307. 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)
85162-003-07
11-Digit CMS (5-4-2)
85162-0003-07

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