Onral Oral Pain Reliever Mouthwash Liquid
NDC Package 85454-0421-1

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

Package Information

Onral Oral Pain Reliever Mouthwash (benzocaine) liquids is shake well upside down.Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.Children under 12 years of age should be supervised in the use of the product.Apply to the affected area.Use up to 4 times daily or as directed by a dentist or doctor.Do not use for teething.Children under 2 years of age: Do not use. This formulation utilizes a liquid delivery system. Marketed by Syka Pharma Inc., this product is identified by NDC 85454-0421 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
85454-0421-1
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 230 mL in 1 BOTTLE, PLASTIC
Product Code
85454-0421
11-Digit Billing Format
85454042101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Onral Oral Pain Reliever Mouthwash
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BENZOCAINE 50 mg/mL
Pharmacologic Class
Usage Information
Shake well upside down.Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.Children under 12 years of age should be supervised in the use of the product.Apply to the affected area.Use up to 4 times daily or as directed by a dentist or doctor.Do not use for teething.Children under 2 years of age: Do not use.

Regulatory & Marketing

Labeler Name
Syka Pharma Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2025
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 85454-0421-1 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 230 ml in 1 bottle, plastic of Onral Oral Pain Reliever Mouthwash, a human over the counter drug labeled by Syka Pharma Inc.. This liquid is formulated for oral 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 Syka Pharma Inc. on July 01, 2025. The current certification is valid through December 31, 2026.

How is this Syka Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85454042101. 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 (5-4-1)
85454-0421-1
11-Digit CMS (5-4-2)
85454-0421-01

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