365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity

Manufacturer
WHOLE FOODS | SOLEVY CO DBA 6 DEGREES COLLECTIVE LLC
Effective date
2026-05-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:57:08

Label at a glance#

Product365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity
Active ingredientFLUORIDE ION
Label structure12 sections

Dosage and administration

• 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 necessa...

Storage and handling

• This rinse is not intended to replace brushing or flossing • Store at room temperature •Cold weather may temporarily cloud this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center (1-800-22-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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.

Other Information.

STORAGE AND HANDLING SECTION

• This rinse is not intended to replace brushing or flossing

• Store at room temperature

•Cold weather may temporarily cloud this product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol (12%), Sorbitol, Polysorbate 80, Stevia Rebaudiana Leaf Extract, Sodium Benzoate, Natural Flavor, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Citric Acid, Sodium Hydroxide.

Questions, Comments?

OTC - QUESTIONS SECTION

1-844-WFM-TALK (1-844-936-8255)

SPL UNCLASSIFIED SECTION

Distributed by: Whole Foods Market | Austin, TX 78703

(c)2024 WHOLE FOODS MARKET IP, INC. | www.wholefoodsmarket.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

combined_labels_reversedcombined_labels_reversed

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN3
313029sodium fluoride 0.2 MG/ML MouthwashSCD3
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY3
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42681-0048-1365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity500 mL in 1 BOTTLEMOUTHWASH5003

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42681-004842681-0048-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-05-01weekly-update2026-06-03 18:02:29

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
ndc (package): 42681-0048-1
ndc (product): 42681-0048
ndc11 (package): 42681004801
spl id: 5105135c-ec41-9f20-e063-6394a90aeb41
spl set id: 25bc7ab1-116d-143a-e063-6394a90aa970

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.