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  5. NDC Package Code: 10237-798-35 Orajel Cold Sore Touch Free - Single Dose

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

Benzalkonium Chloride,Benzocaine Liquid Topical - 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:
10237-798-35
Package Description:
6 VIAL, SINGLE-DOSE in 1 PACKAGE / 3.5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
10237-798
Proprietary Name:
Orajel Cold Sore Touch Free - Single Dose
Non-Proprietary Name:
Benzalkonium Chloride, Benzocaine
Substance Name:
Benzalkonium Chloride; Benzocaine
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
11-Digit NDC Billing Format:
10237079835
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Church & Dwight Co., 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):
  • 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):
  • BENZALKONIUM CHLORIDE 1.3 mg/mL
  • BENZOCAINE 50 mg/mL
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M016
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-01-2021
    Listing Expiration Date:
    12-31-2025
    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 10237-798-35?

    The NDC Packaged Code 10237-798-35 is assigned to a 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.. The product's dosage form is liquid and is administered via topical form.

    Is NDC 10237-798 included in the NDC Directory?

    Yes, Orajel Cold Sore Touch Free - Single Dose with product code 10237-798 is active and included in the NDC Directory. The product was first marketed by Church & Dwight Co., Inc. on September 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 10237-798-35?

    The 11-digit format is 10237079835. 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 5-3-2 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
    5-3-210237-798-355-4-210237-0798-35