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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact 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