Hoo Gargle (apple Spearmint Flavor)
NDC Package 81840-3333-5

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.

Hoo Gargle (apple Spearmint Flavor) is 1. Marketed by Miko Co Ltd, this product is identified by NDC 81840-3333 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
81840-3333-5
Package Description
100 PACKAGE in 1 PACKAGE / 50 PACKAGE in 1 PACKAGE (81840-3333-4) / 30 PACKAGE in 1 PACKAGE (81840-3333-3) / 15 PACKAGE in 1 PACKAGE (81840-3333-2) / 10 POUCH in 1 PACKAGE (81840-3333-1) / 10 mL in 1 POUCH (81840-3333-0)
Product Code
81840-3333
11-Digit Billing Format
81840333305
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
Hoo Gargle (apple Spearmint Flavor)
Dosage Form
-
Usage Information
1. Put one cup in mouth.2. Gargle for 30 sec ~ 1 minute3. Spit it out.5. Rinse with water.

Regulatory & Marketing

Labeler Name
Miko Co Ltd
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2022
Listing Expiration
12-31-2024
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 81840-3333-5 identifies a specific commercial package of 100 package in 1 package / 50 package in 1 package (81840-3333-4) / 30 package in 1 package (81840-3333-3) / 15 package in 1 package (81840-3333-2) / 10 pouch in 1 package (81840-3333-1) / 10 ml in 1 pouch (81840-3333-0) of Hoo Gargle (apple Spearmint Flavor), labeled by Miko 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 Miko Co Ltd on January 01, 2022. The current certification is valid through December 31, 2024.

How is this Miko Co Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81840333305. 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 (5-4-1)
81840-3333-5
11-Digit CMS (5-4-2)
81840-3333-05

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