FDA.reportPublic FDA data

Simply White

Product NDC
51009-248
Requested package NDC
51009-248-47
11-digit product format
510090248
Labeler code
51009
Product ID
51009-248_05e89b65-3c7f-41f7-8fdb-eb8b5530d642
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-29
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage51009-24851009-248-47DDiscontinued by firm2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51009-24851009-248-47DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-248-40Simply WhiteClean Mint1 in 1 CARTONPASTE, DENTIFRICE16
51009-248-40Simply WhiteClean Mint113 g in 1 TUBEPASTE, DENTIFRICE1136
51009-248-47Simply WhiteClean Mint133 g in 1 TUBEPASTE, DENTIFRICE1336
51009-248-47Simply WhiteClean Mint1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W7SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
fluoride ionACTIVE MOIETYQ80VPU408OSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
MentholINACTIVE INGREDIENTL7T10EIP3ASIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Peppermint oilINACTIVE INGREDIENTAV092KU4JHSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ISIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RSIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Xanthan gumINACTIVE INGREDIENTTTV12P4NEESIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ESIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-248SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]5Legacy NDC, 4 package rows20241027_204a3eec-3d91-456d-bc15-51363f25e711.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simply White Clean MintSODIUM FLUORIDETom's of Maine, Inc.204a3eec-3d91-456d-bc15-51363f25e7112025-11-13WarningsExact identifier
ndc (package): 51009-248-47
ndc (product): 51009-248
ndc11 (package): 51009024847

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN204a3eec-3d91-456d-bc15-51363f25e7116
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD204a3eec-3d91-456d-bc15-51363f25e7116
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY204a3eec-3d91-456d-bc15-51363f25e7116
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY204a3eec-3d91-456d-bc15-51363f25e7116
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY204a3eec-3d91-456d-bc15-51363f25e7116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-248-47510090248471 TUBE in 1 CARTON (51009-248-47) > 133 g in 1 TUBE1 tube2011-08-290000-00-00NoNoCurrent