Helocaine Cold Sore Fever Blister Treatment Ointment
NDC Package 83609-212-02

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

Package Information

Helocaine Cold Sore Fever Blister Treatment (tetracaine, mineral) ointment is adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times dailyChildren under the age of 2consult a doctor. This formulation utilizes a ointment delivery system. Marketed by Pagari Life Science Corp., this product is identified by NDC 83609-212 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83609-212-02
Package Description
1 TUBE in 1 BOX / 3 g in 1 TUBE
Product Code
83609-212
11-Digit Billing Format
83609021202
RxNorm Crosswalk
  • RxCUI: 2685213 - mineral oil 74.4 % / tetracaine 2 % Topical Ointment
  • RxCUI: 2685213 - mineral oil 0.744 MG/MG / tetracaine 0.02 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Helocaine Cold Sore Fever Blister Treatment
Non-Proprietary Name
Tetracaine, Mineral
Substance Name
Mineral Oil; Tetracaine
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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
Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times dailyChildren under the age of 2consult a doctor

Regulatory & Marketing

Labeler Name
Pagari Life Science Corp.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2024
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 83609-212-02 identifies a specific commercial package of 1 tube in 1 box / 3 g in 1 tube of Helocaine Cold Sore Fever Blister Treatment, a human over the counter drug labeled by Pagari Life Science Corp.. This ointment is formulated for topical use and contains mineral oil; tetracaine 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 Pagari Life Science Corp. on May 01, 2024. The current certification is valid through December 31, 2027.

How is this Pagari Life Science Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83609021202. 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)
83609-212-02
11-Digit CMS (5-4-2)
83609-0212-02

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