Periactive Mouthwash
NDC Package 49589-111-50

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

Periactive (sambucus nigra flower, echinacea purpurea, and centella asiatica) mouthwashes is adults and children 12 years and olderrinse for 60 seconds with 15ml (3 teaspoonful) twice a daychildren 6-12 yearsrinse for 60 seconds with 10ml (2 teaspoonful) twice a daychildren under 6 years of agedo not usedo not eat, drink or rinse your mouth for 30 minutes after usedo not swallowchildren 6 years to under 12 years of age: supervise use. This formulation utilizes a mouthwash delivery system. Marketed by Izun Pharmaceutical Corporation, this product is identified by NDC 49589-111.

Identification & Billing

NDC Package Code
49589-111-50
Package Description
12 BOTTLE in 1 CARTON / 500 mL in 1 BOTTLE
Product Code
49589-111
11-Digit Billing Format
49589011150

Clinical Specifications

Proprietary Name
Periactive
Non-Proprietary Name
Sambucus Nigra Flower, Echinacea Purpurea, And Centella Asiatica
Substance Name
Centella Asiatica Whole; Echinacea Purpurea Whole; Sambucus Nigra Flower
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
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)
Usage Information
Adults and children 12 years and olderrinse for 60 seconds with 15ml (3 teaspoonful) twice a daychildren 6-12 yearsrinse for 60 seconds with 10ml (2 teaspoonful) twice a daychildren under 6 years of agedo not usedo not eat, drink or rinse your mouth for 30 minutes after usedo not swallowchildren 6 years to under 12 years of age: supervise use

Regulatory & Marketing

Labeler Name
Izun Pharmaceutical Corporation
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
01-11-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49589-111). Click a package code to view its specific billing and regulatory data.

49589-111-10
100 mL in 1 BOTTLE

* 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 49589-111-50 identifies a specific commercial package of 12 bottle in 1 carton / 500 ml in 1 bottle of Periactive, a human over the counter drug labeled by Izun Pharmaceutical Corporation. This mouthwash is formulated for topical use and contains centella asiatica whole; echinacea purpurea whole; sambucus nigra flower 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 Izun Pharmaceutical Corporation on January 11, 2009. The current certification is valid through December 31, 2026.

How is this Izun Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49589011150. 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)
49589-111-50
11-Digit CMS (5-4-2)
49589-0111-50

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