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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact 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