FDA.reportPublic FDA data

Maximum Strength Sensitive

Manufacturer
Tom's of Maine, Inc.
Effective date
2019-09-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:11:59

Label at a glance#

ProductMaximum Strength Sensitive True Mint
Active ingredientSodium Fluoride, Potassium Nitrate
Label structure9 sections

Indications and uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact helps protect against cavities

Dosage and administration

adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Potassium nitrate 5%Tooth desensitizer
Sodium fluoride 0.24% (0.15 w/v fluoride ion)Anticavity

Uses

INDICATIONS & USAGE SECTION

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • helps protect against cavities

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product, do not use longer than 4 weeks unless recommended by a dentist or physician.

OTC - STOP USE SECTION

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, hydrated silica, xylitol, water, glycerin, organic Aloe barbadensis leaf juice, Mentha piperita (peppermint) oil and other natural flavors, cocamidopropyl betaine, xanthan gum, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

SPL UNCLASSIFIED SECTION

© 2010 Tom's of Maine, Inc.
302 Lafayette Ctr.
Kennebunk, ME 04043

PRINCIPAL DISPLAY PANEL - 113 g Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINCE 1970
Tom's
OF MAINE™

maximum strength* | natural

SENSITIVE

clinically proven to reduce painful sensitivity

toothpaste for sensitive teeth
and cavity prevention with fluoride

true mint

NET WT 4.0 OZ (113 g)

Principal Display Panel - 113 g Box
Principal Display Panel - 113 g Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51009-167-042024-11-25C16284748780-1ba0f9c33-32df-a910-e053-dadaa90a0b85Tom's of Maine
51009-167-042021-01-29C16284748780-1ba0f9c33-32df-a910-e053-dadaa90a0b85Tom's of Maine

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Potassium NitrateACTIVE INGREDIENTRU45X2JN0Z2
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W72
Fluoride IonACTIVE MOIETYQ80VPU408O2
Potassium CationACTIVE MOIETY295O53K1522
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X2
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KX2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P92
peppermint oilINACTIVE INGREDIENTAV092KU4JH2
sorbitolINACTIVE INGREDIENT506T60A25R2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2
waterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2
xylitolINACTIVE INGREDIENTVCQ006KQ1E2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-16751009-167-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIB
Potassium NitrateRU45X2JN0ZACTIB
sorbitol506T60A25RIACT
hydrated silicaY6O7T4G8P9IACT
xylitolVCQ006KQ1EIACT
glycerinPDC6A3C0OXIACT
water059QF0KO0RIACT
aloe vera leafZY81Z83H0XIACT
cocamidopropyl betaine5OCF3O11KXIACT
xanthan gumTTV12P4NEEIACT
peppermint oilAV092KU4JHIACT
titanium dioxide15FIX9V2JPIACT
spearmint oilC3M81465G5IACT
menthol, unspecified formL7T10EIP3AIACT
glycyrrhizin6FO62043WKIACT
Anise21C2F5E8REIACT

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 4 · 221 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 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
f6725ec3-1edf-4c62-9827-48434abac9d58a930456-58d6-4a0c-a67c-5aded0add2d02019-09-12WarningsExact identifier
spl set id: 8a930456-58d6-4a0c-a67c-5aded0add2d0

Reported adverse events (FAERS/openFDA)#

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