Orajel Cold Sore Touch Free - Single Dose Liquid
NDC Package 10237-798-35

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

Package Information

Orajel Cold Sore Touch Free - Single Dose (benzalkonium chloride, benzocaine) liquids is •slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. This formulation utilizes a liquid delivery system. Marketed by Church & Dwight Co., Inc., this product is identified by NDC 10237-798 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
10237-798-35
Package Description
6 VIAL, SINGLE-DOSE in 1 PACKAGE / 3.5 mL in 1 VIAL, SINGLE-DOSE
Product Code
10237-798
11-Digit Billing Format
10237079835
RxNorm Crosswalk
  • RxCUI: 2572114 - benzalkonium chloride 0.13 % / benzocaine 5 % Topical Solution
  • RxCUI: 2572114 - benzalkonium chloride 1.3 MG/ML / benzocaine 50 MG/ML Topical Solution

Clinical Specifications

Proprietary Name
Orajel Cold Sore Touch Free - Single Dose
Non-Proprietary Name
Benzalkonium Chloride, Benzocaine
Substance Name
Benzalkonium Chloride; 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
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
•slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin •to treat most cold sores, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstickAdults and children 2 years of age and olderDo not use more than 3 times per dayChildren between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this productChildren under 2 years of ageDo not use

Regulatory & Marketing

Labeler Name
Church & Dwight Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2021
Listing Expiration
12-31-2027
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 10237-798-35 identifies a specific commercial package of 6 vial, single-dose in 1 package / 3.5 ml in 1 vial, single-dose of Orajel Cold Sore Touch Free - Single Dose, a human over the counter drug labeled by Church & Dwight Co., Inc.. This liquid is formulated for topical use and contains benzalkonium chloride; 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 Church & Dwight Co., Inc. on September 01, 2021. The current certification is valid through December 31, 2027.

How is this Church & Dwight Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10237079835. 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)
10237-798-35
11-Digit CMS (5-4-2)
10237-0798-35

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