Toms Whole Care Spearmint

Product NDC
51009-203
11-digit product format
510090203
Labeler code
51009
Product ID
51009-203_c7c81d61-330e-415e-9ceb-fb1e64650467
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
2027-10-31
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 packagepackage51009-20351009-203-47DDiscontinued 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
Toms Whole Care Spearmint
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
ebb62015-0027-459a-a9cf-56b640f9f456Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-203-04Toms Whole Care Spearmintfights cavities whitening fresh breath helps fight tartar113 g in 1 TUBEPASTE, DENTIFRICE1136
51009-203-04Toms Whole Care Spearmintfights cavities whitening fresh breath helps fight tartar1 in 1 CARTONPASTE, DENTIFRICE16
51009-203-47Toms Whole Care Spearmintfights cavities whitening fresh breath helps fight tartar1 in 1 CARTONPASTE, DENTIFRICE16
51009-203-47Toms Whole Care Spearmintfights cavities whitening fresh breath helps fight tartar133 g in 1 TUBEPASTE, DENTIFRICE1336

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium monofluorophosphateACTIVE INGREDIENTC810JCZ56QTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Fluoride ionACTIVE MOIETYQ80VPU408OTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9TOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Spearmint OilINACTIVE INGREDIENTC3M81465G5TOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ETOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Zinc citrateINACTIVE INGREDIENTK72I3DEX9BTOMS WHOLE CARE SPEARMINT 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
51009-203TOMS WHOLE CARE SPEARMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]6Current NDC, Legacy NDC, 4 package rows20241120_ebb62015-0027-459a-a9cf-56b640f9f456.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNebb62015-0027-459a-a9cf-56b640f9f4566
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDebb62015-0027-459a-a9cf-56b640f9f4566
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYebb62015-0027-459a-a9cf-56b640f9f4566
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYebb62015-0027-459a-a9cf-56b640f9f4566
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYebb62015-0027-459a-a9cf-56b640f9f4566
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYebb62015-0027-459a-a9cf-56b640f9f4566

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-203-04510090203041 TUBE in 1 CARTON (51009-203-04) / 113 g in 1 TUBE1 tube2018-11-152027-10-31NoNoCurrent
51009-203-47510090203471 TUBE in 1 CARTON (51009-203-47) > 133 g in 1 TUBE1 tube2014-06-060000-00-00NoNoCurrent