Home NDC 36800-481 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 SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .15; 5 g/100g; g/100g
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topco Associates LLC
Brand name suffix Maximum Strength Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .15 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-481-42 Topco Associates LLCMaximum Strength 113 g in 1 TUBE PASTE, DENTIFRICE 113 9 36800-481-49 Topco Associates LLCMaximum Strength 1 in 1 CARTON PASTE, DENTIFRICE 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 NITRATE ION ACTIVE MOIETY T93E9Y2844 TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 SODIUM PHOSPHATE, TRIBASIC INACTIVE INGREDIENT A752Q30A6X TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-481 TOPCO ASSOCIATES LLC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250119_ac398ff0-0010-4e13-8b89-dc986fd7f974.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 40 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iolite BENZOCAINE Dharma Research, Inc. e4b2d22b-00b3-45a6-9b7d-8ee719587059 2023-10-09 Warnings Exact identifier application number: M022 Iolite BENZOCAINE Dharma Research, Inc. a0e284f6-292f-4231-8596-f7cee4e0a12f 2023-10-09 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC fe92637a-c88a-f9dd-e053-6294a90a7fa3 2023-07-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC c979e958-2042-471a-bf03-e84e68620106 2023-06-20 Warnings Exact identifier application number: M022 Orajel Gum Pain 3X Medicated BENZOCAINE, MENTHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 9a1632ad-2b47-5653-e053-2995a90ae0d9 2023-01-20 Warnings Exact identifier application number: M022 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT BENZOCAINE DMG AMERICA, LLC 0f90b227-f938-4e1a-a79e-1967b1a0477e 2021-10-01 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-481-42 36800048142 113 g in 1 TUBE 113 g Historical 36800-481-49 36800048149 1 TUBE in 1 CARTON (36800-481-49) / 113 g in 1 TUBE (36800-481-42) 1 tube 2012-11-15 2028-06-26 No No Current