FDA.reportPublic FDA data

Top Care

Product NDC
36800-681
11-digit product format
368000681
Labeler code
36800
Product ID
36800-681_4395839a-f420-fe45-e063-6394a90a33d3
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
TOPCO Assoc. LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Top Care
Brand name suffix
Enamel Guard
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-681-19Top CareEnamel Guard113 g in 1 TUBEPASTE, DENTIFRICE1139
36800-681-19Top CareEnamel Guard1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
NITRATE IONACTIVE MOIETYT93E9Y2844TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-681TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]7Current NDC, Legacy NDC, 2 package rows20250119_8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-681-19368000681191 TUBE in 1 CARTON (36800-681-19) / 113 g in 1 TUBE1 tube2012-11-200000-00-00NoNoCurrent