Gelato Topical Anesthetic Spray, Metered
NDC Package 68400-323-35

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

Package Information

Gelato Topical Anesthetic (benzocaine) sprays is a medication used as Oral Anesthetic. This formulation utilizes a spray, metered delivery system. Marketed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc, this product is identified by NDC 68400-323 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
68400-323-35
Package Description
57 g in 1 BOTTLE, SPRAY
Product Code
68400-323
11-Digit Billing Format
68400032335
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gelato Topical Anesthetic
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
BENZOCAINE 11.4 g/57g
Pharmacologic Class
Usage Information
This product is used as Oral Anesthetic. For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.For Professional Use Only.

Regulatory & Marketing

Labeler Name
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-29-2013
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 68400-323-35 identifies a specific commercial package of 57 g in 1 bottle, spray of Gelato Topical Anesthetic, a human over the counter drug labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. This spray, metered is formulated for dental use and contains benzocaine 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 Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc on July 29, 2013. The current certification is valid through December 31, 2026.

How is this Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68400032335. 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)
68400-323-35
11-Digit CMS (5-4-2)
68400-0323-35

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