Releev Cold Sore Treatment Liquid
NDC Package 63287-419-01

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

Package Information

Releev Cold Sore Treatment (benzalkonium chloride) liquids is sHAKE WELL (Adults and children 12 years of age or older) apply to clean, dry, affected area 3-4 times per day by dabbing and pressing solution into the area well. This formulation utilizes a liquid delivery system. Marketed by Merix Pharmaceutical Corp., this product is identified by NDC 63287-419 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
63287-419-01
Package Description
1 POUCH in 1 BLISTER PACK / 1 BOTTLE, DROPPER in 1 POUCH / 1 mL in 1 BOTTLE, DROPPER
Product Code
63287-419
11-Digit Billing Format
63287041901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Releev Cold Sore Treatment
Non-Proprietary Name
Benzalkonium Chloride
Substance Name
Benzalkonium Chloride
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)
BENZALKONIUM CHLORIDE 1.3 mg/mL
Usage Information
SHAKE WELL (Adults and children 12 years of age or older) apply to clean, dry, affected area 3-4 times per day by dabbing and pressing solution into the area well. Allow to dry. Best when used at first sign of outbreak. Do not use cotton applicator.

Regulatory & Marketing

Labeler Name
Merix Pharmaceutical Corp.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63287-419). Click a package code to view its specific billing and regulatory data.

63287-419-03
1 BOTTLE, DROPPER in 1 BLISTER PACK / 3 mL in 1 BOTTLE, DROPPER
63287-419-06
1 BOTTLE, DROPPER in 1 BLISTER PACK / 6 mL in 1 BOTTLE, DROPPER
63287-419-20
1 BOTTLE, SPRAY in 1 CARTON / 60 mL in 1 BOTTLE, SPRAY
63287-419-33
1 BOTTLE, DROPPER in 1 BLISTER PACK / 3 mL in 1 BOTTLE, DROPPER

* 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 63287-419-01 identifies a specific commercial package of 1 pouch in 1 blister pack / 1 bottle, dropper in 1 pouch / 1 ml in 1 bottle, dropper of Releev Cold Sore Treatment, a human over the counter drug labeled by Merix Pharmaceutical Corp.. This liquid is formulated for topical use and contains benzalkonium chloride 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 Merix Pharmaceutical Corp. on June 01, 2006. The current certification is valid through December 31, 2027.

How is this Merix Pharmaceutical Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63287041901. 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)
63287-419-01
11-Digit CMS (5-4-2)
63287-0419-01

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