FDA.reportPublic FDA data

Cavity Protection

Product NDC
51009-120
11-digit product format
510090120
Labeler code
51009
Product ID
51009-120_873dc868-9a54-452c-ae24-e090e8464a05
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
51009-120-552020-01-31C16284748780-19d75b9d0-dad1-f424-e053-dadaa90a57ceTom's OF MAINE CAVITY PROTECTION fluoride toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-120-55Cavity Protection Peppermint with baking soda1 in 1 CARTONPASTE, DENTIFRICE12
51009-120-55Cavity Protection Peppermint with baking soda155.9 g in 1 TUBEPASTE, DENTIFRICE155.92

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
Fluoride ionACTIVE MOIETYQ80VPU408OCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
CarrageenanINACTIVE INGREDIENT5C69YCD2YJCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
Peppermint oilINACTIVE INGREDIENTAV092KU4JHCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
Spearmint OilINACTIVE INGREDIENTC3M81465G5CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2
XylitolINACTIVE INGREDIENTVCQ006KQ1ECAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-120CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2Legacy NDC, 2 package rows20110512_f1cba5ce-852e-424a-b274-4a514505156b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNf1cba5ce-852e-424a-b274-4a514505156b2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf1cba5ce-852e-424a-b274-4a514505156b2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf1cba5ce-852e-424a-b274-4a514505156b2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf1cba5ce-852e-424a-b274-4a514505156b2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf1cba5ce-852e-424a-b274-4a514505156b2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf1cba5ce-852e-424a-b274-4a514505156b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51009-120-55510090120551 in 1 CARTONHistorical