FDA.reportPublic FDA data

Topco Associates LLC

Product NDC
36800-481
11-digit product format
368000481
Labeler code
36800
Product ID
36800-481_3bdd8cfe-1ef8-35cd-e063-6394a90a3165
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Topco Associates LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
Marketing end
2028-06-26
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topco Associates LLC
Brand name suffix
Maximum Strength

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-481-492024-02-23C16284748780-1f386c649-ac5d-0266-e053-dadaa90a7c1a5820184 Topco Max Str Sens Mint
36800-481-492023-01-30C16284748780-1f386c649-ac5d-0266-e053-dadaa90a7c1a5820184 Topco Max Str Sens Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-481-42Topco Associates LLCMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1139
36800-481-49Topco Associates LLCMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
NITRATE IONACTIVE MOIETYT93E9Y2844TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-481TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 2 package rows20250119_ac398ff0-0010-4e13-8b89-dc986fd7f974.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYac398ff0-0010-4e13-8b89-dc986fd7f9749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-481-4236800048142113 g in 1 TUBE113 gHistorical
36800-481-49368000481491 TUBE in 1 CARTON (36800-481-49) / 113 g in 1 TUBE (36800-481-42) 1 tube2012-11-152028-06-26NoNoCurrent