Tom's

Manufacturer
Tom's of Maine, Inc.
Effective date
2026-06-16
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-07-15 00:32:59

Label at a glance#

ProductTom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, calcium carbonate, hydrated silica, xylitol, natural flavor1, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, benzyl alcohol.

1 peppermint oil and other natural flavor

Questions?

OTC - QUESTIONS SECTION

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE ORIGINAL
Tom's
OF MAINE

• NOT TESTED ON
ANIMALS •

NATURAL • WITH FLUORIDE

WHOLE
CARE®

anticavity toothpaste

PEPPERMINT

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

NO
ANIMAL TESTING,
ARTIFICIAL FLAVORS,
SWEETENERS OR DYES

4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixPS0056239toms-01.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium monofluorophosphateACTIVE INGREDIENTC810JCZ56Q1
Fluoride ionACTIVE MOIETYQ80VPU408O1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGK1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJ1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P91
Peppermint OilINACTIVE INGREDIENTAV092KU4JH1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QO1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141J1
WaterINACTIVE INGREDIENT059QF0KO0R1
XylitolINACTIVE INGREDIENTVCQ006KQ1E1
Zinc citrateINACTIVE INGREDIENTK72I3DEX9B1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-20251009-202-47, 51009-202-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-05-28full-release2026-06-01 01:59:13

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 303 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
150 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
150 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
150 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii+route
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii+route
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
150 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
150 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOCAPSULE / ORAL320 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
102 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
150 equally ranked IID candidates

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
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.fdbadaae-eab7-4d9a-acf7-815ca93f877c2026-06-16WarningsExact identifier
ndc (package): 51009-202-47
ndc (package): 51009-202-04
ndc (product): 51009-202
ndc11 (package): 51009020247
ndc11 (package): 51009020204
spl id: 26350c9e-c82e-49bd-b862-74cd7f3ff4f3
spl set id: fdbadaae-eab7-4d9a-acf7-815ca93f877c

Reported adverse events (FAERS/openFDA)#

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