Dentek Eugenol
NDC Package 83062-400-21

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.

Dentek Eugenol is directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Marketed by Iimed Medical Mexicana S. De R.l. De C.v., this product is identified by NDC 83062-400 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
83062-400-21
Package Description
1 VIAL, GLASS in 1 KIT / 3.5 mL in 1 VIAL, GLASS (83062-400-20)
Product Code
83062-400
11-Digit Billing Format
83062040021
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dentek Eugenol
Dosage Form
-
Usage Information
Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by dentist or physician.Adults and children 12 years and older use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years ask a dentist or doctor.

Regulatory & Marketing

Labeler Name
Iimed Medical Mexicana S. De R.l. De C.v.
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
10-10-2022
Listing Expiration
12-31-2023
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 83062-400-21 identifies a specific commercial package of 1 vial, glass in 1 kit / 3.5 ml in 1 vial, glass (83062-400-20) of Dentek Eugenol, labeled by Iimed Medical Mexicana S. De R.l. De C.v.. 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 Iimed Medical Mexicana S. De R.l. De C.v. on October 10, 2022. The current certification is valid through December 31, 2023.

How is this Iimed Medical Mexicana S. De R.l. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83062040021. 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)
83062-400-21
11-Digit CMS (5-4-2)
83062-0400-21

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