Oraqix Gel
NDC Package 66312-110-20

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

Package Information

Oraqix (lidocaine and prilocaine) gel is oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. This formulation utilizes a gel delivery system. Marketed by Dentsply Pharmaceutical, this product is identified by NDC 66312-110 and is authorized under FDA application NDA021451.

Identification & Billing

NDC Package Code
66312-110-20
Package Description
20 APPLICATOR in 1 CARTON / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE
Product Code
66312-110
11-Digit Billing Format
66312011020
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
1.7 GM
RxNorm Crosswalk
  • RxCUI: 897114 - lidocaine 2.5 % / prilocaine 2.5 % Periodontal Gel
  • RxCUI: 897114 - lidocaine 25 MG/ML / prilocaine 25 MG/ML Mucous Membrane Topical Solution
  • RxCUI: 897114 - lidocaine 2.5 % / prilocaine 2.5 % Oromucosal Solution
  • RxCUI: 897117 - oraqix 2.5 % / 2.5 % Periodontal Gel
  • RxCUI: 897117 - lidocaine 25 MG/ML / prilocaine 25 MG/ML Mucous Membrane Topical Solution [Oraqix]

Clinical Specifications

Proprietary Name
Oraqix
Non-Proprietary Name
Lidocaine And Prilocaine
Substance Name
Lidocaine; Prilocaine
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Periodontal - Administration around a tooth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing.

Regulatory & Marketing

Labeler Name
Dentsply Pharmaceutical
Product Type
Human Prescription Drug
FDA Application #
NDA021451
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-02-2004
Listing Expiration
12-31-2027
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 66312-110-20 identifies a specific commercial package of 20 applicator in 1 carton / 1 cartridge in 1 applicator / 1.7 g in 1 cartridge of Oraqix, a human prescription drug labeled by Dentsply Pharmaceutical. This product is billed per "GM" gram and contains an estimated amount of 1.7 billable units per package. This gel is formulated for periodontal use and contains lidocaine; prilocaine 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 Dentsply Pharmaceutical on January 02, 2004. The current certification is valid through December 31, 2027.

How is this Dentsply Pharmaceutical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66312011020. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 1.7 total billable units per package. 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)
66312-110-20
11-Digit CMS (5-4-2)
66312-0110-20

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