Toms

Manufacturer
Tom's of Maine, Inc.
Effective date
2026-06-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-07-15 00:32:59

Label at a glance#

ProductToms Whole Care Spearmint 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 spearmint 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

SPEARMINT

4.0 OZ (113 g)

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

NO
ANIMAL TESTING,
ARTIFICIAL FLAVORS,
SWEETENERS OR DYES

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 MatrixPS0056433toms-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
Spearmint OilINACTIVE INGREDIENTC3M81465G51
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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-20351009-203-47, 51009-203-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-10-15full-release2026-06-01 00:37:53

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 · 306 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XylitolXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
36 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
36 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3059 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
150 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
36 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ 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 ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
150 equally ranked IID candidates
Spearmint OilSPEARMINT OILC3M81465G5PASTE, DENTIFRICE / DENTAL27.6 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRATHECAL0.05 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 ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVENOUS812 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
150 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
150 equally ranked IID candidates
Spearmint OilSPEARMINT OILC3M81465G5PASTE, DENTIFRICE / DENTAL27.6 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
150 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOCAPSULE, DELAYED RELEASE PELLETS / ORAL4 mgExact identifier — unii candidate
102 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
150 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact 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
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.ebb62015-0027-459a-a9cf-56b640f9f4562026-06-16WarningsExact identifier
ndc (package): 51009-203-47
ndc (package): 51009-203-04
ndc (product): 51009-203
ndc11 (package): 51009020347
ndc11 (package): 51009020304
spl id: c7c81d61-330e-415e-9ceb-fb1e64650467
spl set id: ebb62015-0027-459a-a9cf-56b640f9f456

Reported adverse events (FAERS/openFDA)#

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