365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity

FLUORIDE ORAL HUMAN OTC DRUG

365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity is an FDA drug label for the active ingredient FLUORIDE manufactured by WHOLE FOODS administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260504.

Generic name
FLUORIDE
Manufacturer
WHOLE FOODS
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
42681-0048
Application
M022
Label effective
20260504

About this product

365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity is an FDA-registered drug product whose active ingredient is FLUORIDE. It is labelled by WHOLE FOODS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 42681-0048, application M022, label effective 20260504. It is one of 4 FDA drug label records sharing the active ingredient FLUORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing FLUORIDE are most often described in connection with: prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient Sodium Fluoride 0.02% (0.01% w/v fluoride Ion)

Indications & Usage

Use Aids in the prevention of dental cavities

Dosage & Administration

Directions • 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.

Warnings

Warnings keep out of reach of children.

More products with the same ingredient

FLUORIDE

Lornamead Natural White

Lornamead Products View label

Natural White Radiant White

Lornamead Products View label

Quality Choice Natural White

CHAIN DRUG MARKETING ASSOCIATION INC View label

How products containing FLUORIDE compare

FDA lists 4 drug label records with FLUORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Lornamead Products 2
— — CHAIN DRUG MARKETING ASSOCIATION INC 1
— — WHOLE FOODS 1
— — — —
— — — —

Frequently asked questions

What is 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity used for?
Use Aids in the prevention of dental cavities

Who makes 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity?
WHOLE FOODS is the labeler of record for 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity. 4 FDA label records share the active ingredient FLUORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FLUORIDE?
Yes. 4 FDA drug label records list FLUORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.