FDA.reportPublic FDA data

Whole Care

Product NDC
51009-105
11-digit product format
510090105
Labeler code
51009
Product ID
51009-105_3452f64a-225d-428c-95d3-df5bd9c8d826
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-02-14
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
0 g/g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51009-105-472020-01-31C16284748780-19d75b9cf-f863-f424-e053-dadaa90a57ceTom's OF MAINE WHOLE CARE fluoride toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-105-47Whole Care Spearmint1 in 1 CARTONPASTE, DENTIFRICE11
51009-105-47Whole Care Spearmint133 g in 1 TUBEPASTE, DENTIFRICE1331

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium monofluorophosphateACTIVE INGREDIENTC810JCZ56QWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
fluoride ionACTIVE MOIETYQ80VPU408OWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Cinnamon leaf oilINACTIVE INGREDIENTS92U8SQ71VWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Clove oilINACTIVE INGREDIENT578389D6D0WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Clove stem oilINACTIVE INGREDIENT9368YZM9M4WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Methyl salicylateINACTIVE INGREDIENTLAV5U5022YWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Spearmint OilINACTIVE INGREDIENTC3M81465G5WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Zinc citrateINACTIVE INGREDIENTK72I3DEX9BWHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-105WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1Legacy NDC, 2 package rows20110222_7f20f8a0-75f9-4365-b00a-a53c6a35b448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN7f20f8a0-75f9-4365-b00a-a53c6a35b4481
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7f20f8a0-75f9-4365-b00a-a53c6a35b4481
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7f20f8a0-75f9-4365-b00a-a53c6a35b4481
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7f20f8a0-75f9-4365-b00a-a53c6a35b4481
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7f20f8a0-75f9-4365-b00a-a53c6a35b4481
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7f20f8a0-75f9-4365-b00a-a53c6a35b4481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51009-105-47510090105471 in 1 CARTONHistorical