365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity Mouthwash
NDC Package 42681-0048-1

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

Package Information

365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity (fluoride) mouthwashes is • Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste. This formulation utilizes a mouthwash delivery system. Marketed by Whole Foods, this product is identified by NDC 42681-0048 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
42681-0048-1
Package Description
500 mL in 1 BOTTLE
Product Code
42681-0048
11-Digit Billing Format
42681004801
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
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity
Non-Proprietary Name
Fluoride
Substance Name
Fluoride Ion
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUORIDE ION .1 mg/mL
Usage Information
• Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste. •Vigorously swish 10 milliliters (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out. •Do not swallow the rinse. •Do not eat or drink for 30 minutes after rinsing.•Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). •Supervise children as necessary until capable of using without supervision.• Children under 6 years of age: consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Whole Foods
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-31-2026
Listing Expiration
12-31-2027
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 42681-0048-1 identifies a specific commercial package of 500 ml in 1 bottle of 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity, a human over the counter drug labeled by Whole Foods. This mouthwash is formulated for oral use and contains fluoride ion 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 Whole Foods on March 31, 2026. The current certification is valid through December 31, 2027.

How is this Whole Foods product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42681004801. 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)
42681-0048-1
11-Digit CMS (5-4-2)
42681-0048-01

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