FDA.reportPublic FDA data

Simply White

Product NDC
51009-248
11-digit product format
510090248
Labeler code
51009
Product ID
51009-248_cddbabef-2113-4acf-82c6-c493657185dd
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
2011-08-29
Marketing end
2026-10-01
Substance
SODIUM FLUORIDE
Active strength
.00243 g/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Simply White
Brand name suffix
Clean Mint

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

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.]5Current NDC, Legacy NDC, 4 package rows20241027_204a3eec-3d91-456d-bc15-51363f25e711.zip

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
51009-248-40510090248401 TUBE in 1 CARTON (51009-248-40) / 113 g in 1 TUBE1 tube2023-09-302026-10-01NoNoHistorical
51009-248-47510090248471 TUBE in 1 CARTON (51009-248-47) > 133 g in 1 TUBE1 tube2011-08-290000-00-00NoNoCurrent