Emmi-dent Whitening Paste, Dentifrice
NDC Package 63956-003-03

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

Package Information

Emmi-dent Whitening (sodium fluoride) pastes is *adults and children 2 yrs. This formulation utilizes a paste, dentifrice delivery system. Marketed by Emag Ag, this product is identified by NDC 63956-003 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
63956-003-03
Package Description
1 TUBE in 1 CARTON / 75 mL in 1 TUBE
Product Code
63956-003
11-Digit Billing Format
63956000303

Clinical Specifications

Proprietary Name
Emmi-dent Whitening
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 320 mg/75mL
Usage Information
*adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist*do not swallow*to minimize swallowing use a pea-sized amount in children unter 6*supervise children's dental cleaning until good habits are established*children under 2 yrs.: ask a dentist

Regulatory & Marketing

Labeler Name
Emag Ag
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-30-2019
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 63956-003-03 identifies a specific commercial package of 1 tube in 1 carton / 75 ml in 1 tube of Emmi-dent Whitening, a human over the counter drug labeled by Emag Ag. 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 Emag Ag on July 30, 2019. The current certification is valid through December 31, 2026.

How is this Emag Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63956000303. 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)
63956-003-03
11-Digit CMS (5-4-2)
63956-0003-03

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