Plak Smacker
NDC Package 71775-080-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Plak Smacker is adults and children 2 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 2 to 6 years: To minimize swallowing use a pea sized amount. Marketed by Lmz, this product is identified by NDC 71775-080 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
71775-080-01
Package Description
28 g in 1 TUBE
Product Code
71775-080
11-Digit Billing Format
71775008001
RxNorm Crosswalk
  • RxCUI: 891775 - sodium fluoride 0.243 % Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Plak Smacker Mint Blast
Dosage Form
-
Usage Information
Adults and children 2 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 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established.Children under 2 years: Ask a dentist or a physician.

Regulatory & Marketing

Labeler Name
Lmz
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-18-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71775-080-01 identifies a specific commercial package of 28 g in 1 tube of Plak Smacker Mint Blast, labeled by Lmz. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lmz on March 18, 2021. The current certification is valid through December 31, 2022.

How is this Lmz product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71775008001. 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)
71775-080-01
11-Digit CMS (5-4-2)
71775-0080-01

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