Toms Cavity Protection Spearmint

Manufacturer
Tom's of Maine, Inc.
Effective date
2019-09-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:13:22

Label at a glance#

ProductToms Cavity Protection Spearmint Fights cavities Fresh Breath
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% (0.16% 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

calcium carbonate, water, glycerin, xylitol, sodium lauryl sulfate, natural flavor1, carrageenan, 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 - 155.9 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINCE 1970
Tom's
OF MAINE®

natural

CAVITY PROTECTION

fluoride toothpaste
fights cavities | fresh breath
no artificial dyes or sweeteners

spearmint

NET WT 5.5 OZ (155.9 g)

PRINCIPAL DISPLAY PANEL - 155.9 g Tube Carton
PRINCIPAL DISPLAY PANEL - 155.9 g Tube Carton

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
Peppermint oilINACTIVE INGREDIENTAV092KU4JH1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QO1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141J1
Spearmint OilINACTIVE INGREDIENTC3M81465G51
WaterINACTIVE INGREDIENT059QF0KO0R1
XylitolINACTIVE INGREDIENTVCQ006KQ1E1

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
51009-21051009-210-55

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

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 5 · 266 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JINSERT / VAGINAL15 mgExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET / BUCCAL5.18 mgExact identifier — unii candidate
42 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE PELLETS / ORAL99 mgExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3059 mgExact identifier — unii candidate
34 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING / ORAL16 mgExact identifier — unii candidate
42 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
CarrageenanCARRAGEENAN5C69YCD2YJCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, FILM COATED / ORAL86 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
Peppermint oilPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
34 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
fe1c1d22-2b28-46f4-bf76-399cfa736c2a8df2691c-e0f7-4d2f-b444-1e9d60e12c4d2022-12-19WarningsExact identifier
spl set id: 8df2691c-e0f7-4d2f-b444-1e9d60e12c4d

Reported adverse events (FAERS/openFDA)#

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