FDA.reportPublic FDA data

Natural Fluoride Fresh Mint

Product NDC
51009-238
11-digit product format
510090238
Labeler code
51009
Product ID
51009-238_c44d04bf-0238-4cb6-b0f4-a0aa83561892
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-01
Marketing end
2027-08-31
Substance
SODIUM FLUORIDE
Active strength
.00243 g/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
Natural Fluoride Fresh Mint
Brand name suffix
cavity protection whitening fresh breath

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.00243 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fce5e8b5-34f8-4a45-a662-82c903419809Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-238-59Natural Fluoride Fresh Mintcavity protection whitening fresh breath85 g in 1 TUBEPASTE, DENTIFRICE855

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W7NATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
fluoride ionACTIVE MOIETYQ80VPU408ONATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9NATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Peppermint oilINACTIVE INGREDIENTAV092KU4JHNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RNATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Xanthan gumINACTIVE INGREDIENTTTV12P4NEENATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ENATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-238NATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]4Current NDC, Legacy NDC, 1 package rows20241122_fce5e8b5-34f8-4a45-a662-82c903419809.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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden Sensitive Care ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD3fb153f1-ba6e-7251-e063-6294a90abe622025-09-26WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEDONG IL PHARMS CO.,LTD3fb1a2ee-381e-a9e8-e063-6394a90a864b2025-09-26WarningsExact identifier
application number: M021
unpa Cha Cha ToothpasteSODIUM MONOFLUOROPHOSPHATELycl Inc.230b3cf2-053a-4e8b-8d50-05bbc877faa82025-09-25WarningsExact identifier
application number: M021
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b12025-09-18WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCc1bbdd36-53fb-43a3-ba20-afbeb6359d312025-09-18WarningsExact identifier
application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.f70d378b-d4d6-454c-90a9-794459960c8c2025-09-17WarningsExact identifier
application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.26b9b2dd-7cb2-47c3-8bbb-94a48f02dd212025-09-16WarningsExact identifier
application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.3436532d-e078-4dbb-a823-b4542e9615342025-09-16WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release Fresh MintSTANNOUS FLUORIDEColgate-Palmolive Company9b1671c4-8680-6e2a-9f10-0400840ca5a92025-09-12WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyddc09ce5-181a-1b50-7094-314bb58a15cf2025-09-12WarningsExact identifier
application number: M021
Cavity Protection Fresh Mint Anticavity MouthwashSODIUM FLUORIDEOxyfresh Worldwide Inc3efc66b2-fcf9-4d26-9cdd-1af8225312b42025-09-10WarningsExact identifier
application number: M021
CLOSE UP Freshening with MouthwashSODIUM FLUORIDEChurch & Dwight Co., Inc.e660b0d7-4cc5-4028-bdf5-016b858997282025-09-09WarningsExact identifier
application number: M021
Essentials Healthy Teeth and GumsSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.9652c004-6b47-840f-e053-2995a90a6e982025-09-09WarningsExact identifier
application number: M021
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.e911effb-d59f-4054-9501-803b64369ab42025-09-05WarningsExact identifier
application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD3de10638-1a39-b747-e063-6294a90a4ca52025-09-03WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
application number: M021
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc.fc794fe5-7135-4b2b-b002-a75908223f202025-08-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNfce5e8b5-34f8-4a45-a662-82c9034198095
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDfce5e8b5-34f8-4a45-a662-82c9034198095
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYfce5e8b5-34f8-4a45-a662-82c9034198095
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYfce5e8b5-34f8-4a45-a662-82c9034198095
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYfce5e8b5-34f8-4a45-a662-82c9034198095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-238-595100902385985 g in 1 TUBE (51009-238-59) 85 g2012-09-012027-08-31NoNoCurrent