FDA.reportPublic FDA data

Childrens

Product NDC
51009-127
11-digit product format
510090127
Labeler code
51009
Product ID
51009-127_14754960-8e32-4c3c-b41d-f5ed6fdc2c74
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
2010-08-30
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
51009-127-042020-01-31C16284748780-19d75b9d0-23fe-f424-e053-dadaa90a57ceTom's ™ OF MAINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-127-04ChildrensOutrageous Orange Mango113 g in 1 TUBEPASTE, DENTIFRICE1131
51009-127-04ChildrensOutrageous Orange Mango1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
fluoride ionACTIVE MOIETYQ80VPU408OCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated silicaINACTIVE INGREDIENTY6O7T4G8P9CHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
OrangeINACTIVE INGREDIENT5EVU04N5QUCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-127CHILDRENS OUTRAGEOUS ORANGE MANGO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1Legacy NDC, 2 package rows20100915_4d4cf5c7-bac2-46b2-bd71-bb27f2038286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN4d4cf5c7-bac2-46b2-bd71-bb27f20382861
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4d4cf5c7-bac2-46b2-bd71-bb27f20382861
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4d4cf5c7-bac2-46b2-bd71-bb27f20382861
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4d4cf5c7-bac2-46b2-bd71-bb27f20382861
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4d4cf5c7-bac2-46b2-bd71-bb27f20382861
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4d4cf5c7-bac2-46b2-bd71-bb27f20382861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51009-127-0451009012704113 g in 1 TUBE113 gHistorical