OTC - ACTIVE INGREDIENT SECTION
Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Thymol 0.064%
Sodium Fluoride 0.02% (0.01% w/v fluoride ion)
365 Whole Foods Market Anticavity/Antigingivitis Mouthwash
- Manufacturer
- Whole Foods Market, Inc.
- Effective date
- 2022-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:52:19
Label at a glance#
Product365 Whole Foods Market Anticavity/Antigingivitis Mouthwash
Active ingredientMETHYL SALICYLATE, SODIUM FLUORIDE, MENTHOL, THYMOL, EUCALYPTOL
Label structure8 sections
Label contents#
Full prescribing information#
DOSAGE & ADMINISTRATION SECTION
Directions Adults and children 12 years of age and older: Use twice a day after brushing your teeth with a toothpaste • Vigorously swish 10mL of rinse between your teeth for 30 seconds and then spit out. Do not swallow the rinse • Do not eat or drink for 30 minutes after rinsing. • Children under 12 years of age: do not use/consult a doctor.
WARNINGS SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
OTC - STOP USE SECTION
• Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
INACTIVE INGREDIENT SECTION
Inactive ingredients: water, ethyl alcohol (21.6% v/v), sorbitol, flavor, cocamidopropyl betaine, citric acid, stevia rebaudiana leaf extract, sodium citrate, sodium benzoate, mentha piperita (peppermint) oil, mentha spicata (spearmint) oil.
RECENT MAJOR CHANGES SECTION
Highlights:
• Dosage and Administration 24 Jan 2022
INDICATIONS & USAGE SECTION
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.
OTC - PURPOSE SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42681-0036-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-64b3-111a-e063-dadaa90a10e2 | WFM PLD Listing Mouthwash with Fluoride |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42681-0036-1 | 365 Whole Foods Market Anticavity/Antigingivitis Mouthwash | 946 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 946 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42681-0036 | 365 WHOLE FOODS MARKET ANTICAVITY/ANTIGINGIVITIS MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL, SODIUM FLUORIDE) MOUTHWASH [WHOLE FOODS MARKET, INC.] | 4 | Legacy NDC, 1 package rows | 20221208_d659c511-5a55-694c-e053-2a95a90a684f.zip |
Products#
Every source-derived product name is available through these pages.
- 365 Whole Foods Market Anticavity/Antigingivitis Mouthwash
- Eucalyptol, Menthol, Methyl Salicylate, Thymol, Sodium Fluoride
- METHYL SALICYLATE
- SALICYLIC ACID
- SORBITOL
- SODIUM BENZOATE
- ALCOHOL
- SODIUM FLUORIDE
- FLUORIDE ION
- WATER
- COCAMIDOPROPYL BETAINE
- MENTHOL
- SODIUM CITRATE
- ANHYDROUS CITRIC ACID
- PEPPERMINT OIL
- THYMOL
- SPEARMINT OIL
- EUCALYPTOL
- STEVIA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42681-0036 | 42681-0036-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| SORBITOL | 506T60A25R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| WATER | 059QF0KO0R | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| THYMOL | 3J50XA376E | ACTIB |
| SPEARMINT OIL | C3M81465G5 | IACT |
| EUCALYPTOL | RV6J6604TK | ACTIB |
| STEVIA LEAF | 6TC6NN0876 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ded13147-455d-52f1-e053-2a95a90afb29 | d659c511-5a55-694c-e053-2a95a90a684f | 2022-05-12 | Warnings | ded13147-455d-52f1-e053-2a95a90afb29 d659c511-5a55-694c-e053-2a95a90a684f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.