Amosan Oral Wound Cleanser Spearmint Powder, For Solution
NDC Package 71223-003-00

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

Package Information

Amosan Oral Wound Cleanser Spearmint (sodium perborate monohydrate) powders is adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm wateruse immediatelyswish solution around in the mouth over the effected area or gargle for least 1 minute and then spit it outdo not swallowuse up to 4 times daily after meals and at bedtime or as directed by a dentist or doctorchildren under 12 years of age should be supervised in the use of this productconsult a dentist or doctor for use in children under 6 years of age. This formulation utilizes a powder, for solution delivery system. Marketed by Vintage Brands Limited, this product is identified by NDC 71223-003 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
71223-003-00
Package Description
12 PACKET in 1 CARTON / 1.7 g in 1 PACKET
Product Code
71223-003
11-Digit Billing Format
71223000300

Clinical Specifications

Proprietary Name
Amosan Oral Wound Cleanser Spearmint
Non-Proprietary Name
Sodium Perborate Monohydrate
Substance Name
Sodium Perborate Monohydrate
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM PERBORATE MONOHYDRATE 1.2 g/1.7g
Usage Information
Adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm wateruse immediatelyswish solution around in the mouth over the effected area or gargle for least 1 minute and then spit it outdo not swallowuse up to 4 times daily after meals and at bedtime or as directed by a dentist or doctorchildren under 12 years of age should be supervised in the use of this productconsult a dentist or doctor for use in children under 6 years of age

Regulatory & Marketing

Labeler Name
Vintage Brands Limited
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71223-003-00 identifies a specific commercial package of 12 packet in 1 carton / 1.7 g in 1 packet of Amosan Oral Wound Cleanser Spearmint, a human over the counter drug labeled by Vintage Brands Limited. This powder, for solution is formulated for oral use and contains sodium perborate monohydrate 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 Vintage Brands Limited on April 01, 2024. The current certification is valid through December 31, 2026.

How is this Vintage Brands Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71223000300. 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)
71223-003-00
11-Digit CMS (5-4-2)
71223-0003-00

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