Listerine Essential Care Gel, Dentifrice
NDC Package 69968-0701-4

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

Package Information

Listerine Essential Care (sodium monofluorophosphate) gel is adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.children 2-6 years use a pea sized amountinstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervision.children under 2 years of age: ask a dentist or doctor. This formulation utilizes a gel, dentifrice delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 69968-0701 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
69968-0701-4
Package Description
1 TUBE in 1 CARTON / 119 g in 1 TUBE
Product Code
69968-0701
11-Digit Billing Format
69968070104
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Listerine Essential Care
Non-Proprietary Name
Sodium Monofluorophosphate
Substance Name
Sodium Monofluorophosphate
Dosage Form
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM MONOFLUOROPHOSPHATE 1.3 mg/g
Usage Information
Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.children 2-6 years use a pea sized amountinstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervision.children under 2 years of age: ask a dentist or doctor

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-03-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69968-0701-4 identifies a specific commercial package of 1 tube in 1 carton / 119 g in 1 tube of Listerine Essential Care, a human over the counter drug labeled by Kenvue Brands Llc. This gel, dentifrice is formulated for oral use and contains sodium monofluorophosphate 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 Kenvue Brands Llc on March 03, 2021. The current certification is valid through December 31, 2026.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69968070104. 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 (5-4-1)
69968-0701-4
11-Digit CMS (5-4-2)
69968-0701-04

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