Iolite-s Spray
NDC Package 53045-127-60

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

Package Information

Iolite-s (benzocaine) sprays is shake well before use. This formulation utilizes a spray delivery system. Marketed by Dharma Research, Inc., this product is identified by NDC 53045-127 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
53045-127-60
Package Description
60 mL in 1 BOTTLE, SPRAY
Product Code
53045-127
11-Digit Billing Format
53045012760

Clinical Specifications

Proprietary Name
Iolite-s
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
BENZOCAINE 12 g/100mL
Pharmacologic Class
Usage Information
Shake well before use. Firmly insert extension tube into spray can valve and ensure it fits securely in the actuator opening. Position the extension tube 1-2 inches from the affected area. Press 1/2 second (press and immediately release the actuator).Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age should be supervised in the use of this product.Children under 2 years of age: do not use.

Regulatory & Marketing

Labeler Name
Dharma Research, Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-04-2021
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 53045-127-60 identifies a specific commercial package of 60 ml in 1 bottle, spray of Iolite-s, a human over the counter drug labeled by Dharma Research, Inc.. This spray 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 Dharma Research, Inc. on January 04, 2021. The current certification is valid through December 31, 2026.

How is this Dharma Research, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53045012760. 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)
53045-127-60
11-Digit CMS (5-4-2)
53045-0127-60

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