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  5. NDC Package Code: 85454-0421-1 Onral Oral Pain Reliever Mouthwash

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

Benzocaine Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
85454-0421-1
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 230 mL in 1 BOTTLE, PLASTIC
Product Code:
85454-0421
Proprietary Name:
Onral Oral Pain Reliever Mouthwash
Non-Proprietary Name:
Benzocaine
Substance Name:
Benzocaine
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.
11-Digit NDC Billing Format:
85454042101
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Syka Pharma Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
BENZOCAINE 50 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M022
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
07-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 85454-0421-1?

The NDC Packaged Code 85454-0421-1 is assigned to a 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.. The product's dosage form is liquid and is administered via oral form.

Is NDC 85454-0421 included in the NDC Directory?

Yes, Onral Oral Pain Reliever Mouthwash with product code 85454-0421 is active and included in the NDC Directory. The product was first marketed by Syka Pharma Inc. on July 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85454-0421-1?

The 11-digit format is 85454042101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-185454-0421-15-4-285454-0421-01