365 Whole Foods Market Anticavity/antigingivitis Mouthwash
NDC Package 42681-0036-1

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.

365 Whole Foods Market Anticavity/antigingivitis Mouthwash is uses • Aids in the prevention of dental cavities. Marketed by Whole Foods Market, Inc., this product is identified by NDC 42681-0036 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
42681-0036-1
Package Description
946 mL in 1 BOTTLE, PLASTIC
Product Code
42681-0036
11-Digit Billing Format
42681003601

Clinical Specifications

Proprietary Name
365 Whole Foods Market Anticavity/antigingivitis Mouthwash
Dosage Form
-
Usage Information
Uses • Aids in the prevention of dental cavities. • Helps remove plaque that leads to gingivitis, an early form of gum disease. • The combined daily use of a fluoride preventative treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

Regulatory & Marketing

Labeler Name
Whole Foods Market, Inc.
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
01-31-2022
Listing Expiration
12-31-2023
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 42681-0036-1 identifies a specific commercial package of 946 ml in 1 bottle, plastic of 365 Whole Foods Market Anticavity/antigingivitis Mouthwash, labeled by Whole Foods Market, Inc.. 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 Whole Foods Market, Inc. on January 31, 2022. The current certification is valid through December 31, 2023.

How is this Whole Foods Market, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42681003601. 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)
42681-0036-1
11-Digit CMS (5-4-2)
42681-0036-01

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