FDA.reportPublic FDA data

Tom Whole Care Peppermint

Product NDC
51009-202
Requested package NDC
51009-202-04
11-digit product format
510090202
Labeler code
51009
Product ID
51009-202_26350c9e-c82e-49bd-b862-74cd7f3ff4f3
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-06
Marketing end
2027-11-30
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.4 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Tom Whole Care Peppermint
Brand name suffix
fights cavities whitening fresh breath helps fight tartar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdbadaae-eab7-4d9a-acf7-815ca93f877cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-202-04Tom Whole Care Peppermintfights cavities whitening fresh breath helps fight tartar1 in 1 CARTONPASTE, DENTIFRICE19
51009-202-04Tom Whole Care Peppermintfights cavities whitening fresh breath helps fight tartar113 g in 1 TUBEPASTE, DENTIFRICE1139
51009-202-47Tom Whole Care Peppermintfights cavities whitening fresh breath helps fight tartar133 g in 1 TUBEPASTE, DENTIFRICE1339
51009-202-47Tom Whole Care Peppermintfights cavities whitening fresh breath helps fight tartar1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium monofluorophosphateACTIVE INGREDIENTC810JCZ56QTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Fluoride ionACTIVE MOIETYQ80VPU408OTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9TOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ETOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Zinc citrateINACTIVE INGREDIENTK72I3DEX9BTOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-202TOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]7Current NDC, Legacy NDC, 4 package rows20241124_fdbadaae-eab7-4d9a-acf7-815ca93f877c.zip

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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNfdbadaae-eab7-4d9a-acf7-815ca93f877c9
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDfdbadaae-eab7-4d9a-acf7-815ca93f877c9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYfdbadaae-eab7-4d9a-acf7-815ca93f877c9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYfdbadaae-eab7-4d9a-acf7-815ca93f877c9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYfdbadaae-eab7-4d9a-acf7-815ca93f877c9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYfdbadaae-eab7-4d9a-acf7-815ca93f877c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-202-04510090202041 TUBE in 1 CARTON (51009-202-04) / 113 g in 1 TUBE1 tube2018-10-292027-11-30NoNoCurrent