Orasep Liquid
NDC Package 54859-503-01

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

Package Information

Orasep (benzocaine, menthol, cetylpyridinium chloride) liquids is in the event of accidental contact with eyes, flush immediately with water and continuosly for 10 minutes. This formulation utilizes a liquid delivery system. Marketed by Llorens Pharmaceutical International Division, this product is identified by NDC 54859-503 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
54859-503-01
Package Description
30 mL in 1 BOTTLE
Product Code
54859-503
11-Digit Billing Format
54859050301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk
  • RxCUI: 1362704 - benzocaine 2 % / menthol 0.5 % / cetylpyridinium chloride 0.1 % Mucous Membrane Topical Solution
  • RxCUI: 1362704 - benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucous Membrane Topical Solution
  • RxCUI: 1362704 - benzocaine 2 % / cetylpyridinium chloride 0.1 % / menthol 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 1547767 - Orasep (2 % / 0.1 % / 0.5 % ) Mucous Membrane Topical Solution, Reformulated Dec 2013
  • RxCUI: 1547767 - benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucous Membrane Topical Solution [Orasep Reformulated Dec 2013]

Clinical Specifications

Proprietary Name
Orasep
Non-Proprietary Name
Benzocaine, Menthol, Cetylpyridinium Chloride
Substance Name
Benzocaine; Cetylpyridinium Chloride; Menthol
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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
In the event of accidental contact with eyes, flush immediately with water and continuosly for 10 minutes. Sek immediate medical attention if pain persists.Other Information: Tamper Evident Feature: Do not use if heat seal under cap is torn, broken or missing. Store at controlled room temperature 15-30 degree celcius ( 59-86 degree arenheit).

Regulatory & Marketing

Labeler Name
Llorens Pharmaceutical International Division
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2010
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 54859-503-01 identifies a specific commercial package of 30 ml in 1 bottle of Orasep, a human over the counter drug labeled by Llorens Pharmaceutical International Division. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This liquid is formulated for topical use and contains benzocaine; cetylpyridinium chloride; menthol 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 Llorens Pharmaceutical International Division on April 01, 2010. The current certification is valid through December 31, 2026.

How is this Llorens Pharmaceutical International Division product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54859050301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 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)
54859-503-01
11-Digit CMS (5-4-2)
54859-0503-01

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