FDA.reportPublic FDA data

Toms Wicked Fresh Cool Peppermint

Product NDC
51009-205
11-digit product format
510090205
Labeler code
51009
Product ID
51009-205_3d6ec4f5-dfc9-4504-96ed-26d5ebbd5126
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-08
Marketing end
2027-10-31
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Toms Wicked Fresh Cool Peppermint
Brand name suffix
fresh breath / cavity protection

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-205-40Toms Wicked Fresh Cool Peppermintfresh breath / cavity protection1 in 1 CARTONPASTE, DENTIFRICE16
51009-205-40Toms Wicked Fresh Cool Peppermintfresh breath / cavity protection113 g in 1 TUBEPASTE, DENTIFRICE1136
51009-205-47Toms Wicked Fresh Cool Peppermintfresh breath / cavity protection133 g in 1 TUBEPASTE, DENTIFRICE1336
51009-205-47Toms Wicked Fresh Cool Peppermintfresh breath / cavity protection1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Fluoride ionACTIVE MOIETYQ80VPU408OTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
CinnamaldehydeINACTIVE INGREDIENTSR60A3XG0FTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Clove OilINACTIVE INGREDIENT578389D6D0TOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662TOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9TOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
LicoriceINACTIVE INGREDIENT61ZBX54883TOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
MentholINACTIVE INGREDIENTL7T10EIP3ATOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
Star Anise OilINACTIVE INGREDIENT6RXP35EIRETOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
VanillinINACTIVE INGREDIENTCHI530446XTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ETOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-205TOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]6Current NDC, Legacy NDC, 4 package rows20241027_1c029b10-29b0-4131-9134-cebfca4328a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-205-40510090205401 TUBE in 1 CARTON (51009-205-40) / 113 g in 1 TUBE1 tube2023-09-30NoNoHistorical
51009-205-47510090205471 TUBE in 1 CARTON (51009-205-47) > 133 g in 1 TUBE1 tube2014-06-060000-00-00NoNoCurrent