Tom Whole Care Peppermint

Product NDC
51009-202
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51009-20251009-202-47DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact 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
51009-202-47510090202471 TUBE in 1 CARTON (51009-202-47) > 133 g in 1 TUBE1 tube2014-06-060000-00-00NoNoCurrent