Home NDC 36800-364 Topco Associates LLC
Product NDC 36800-364
11-digit product format 368000364
Labeler code 36800
Product ID 36800-364_47e514c6-af35-cdd8-e063-6394a90aea44
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 2025-06-26
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .15; 5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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
Listing expiration 2027-12-31 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-364-10 Topco Associates LLCMaximum Strength 1 in 1 CARTON PASTE, DENTIFRICE 1 3 36800-364-10 Topco Associates LLCMaximum Strength 113 g in 1 TUBE PASTE, DENTIFRICE 113 3
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 27 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 36800-364-10 36800036410 1 TUBE in 1 CARTON (36800-364-10) / 113 g in 1 TUBE 1 tube 2025-06-26 No No Current