Olidental Gargle
NDC Package 70417-001-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Olidental Gargle is aids in the prevention of dental cavities. Marketed by Aju Pharm Co., Ltd., this product is identified by NDC 70417-001 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
70417-001-01
Package Description
300 mL in 1 BOTTLE
Product Code
70417-001
11-Digit Billing Format
70417000101
RxNorm Crosswalk
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse
  • RxCUI: 313029 - sodium fluoride 0.2 MG/ML Mouthwash
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse

Clinical Specifications

Proprietary Name
Olidental Gargle
Dosage Form
-
Usage Information
Aids in the prevention of dental cavities

Regulatory & Marketing

Labeler Name
Aju Pharm Co., Ltd.
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-20-2016
Listing Expiration
12-31-2017
Exclude Flag
I
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 70417-001-01 identifies a specific commercial package of 300 ml in 1 bottle of Olidental Gargle, labeled by Aju Pharm Co., Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aju Pharm Co., Ltd. on January 20, 2016. The current certification is valid through December 31, 2017.

How is this Aju Pharm Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70417000101. 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)
70417-001-01
11-Digit CMS (5-4-2)
70417-0001-01

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