Home NDC 59883-720 Pro-Den Rx
Product NDC 59883-720
11-digit product format 598830720
Labeler code 59883
Product ID 59883-720_0a95fcbe-e811-031d-e063-6294a90aec1b
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form RINSE
Route ORAL
Labeler Den-mat Holdings, Llc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-10-31
Substance STANNOUS FLUORIDE
Active strength 1.53 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Pro-Den Rx
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 1.53 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII 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 59883-720-08 Pro-Den Rx 283.5 g in 1 BOTTLE RINSE 283.5 6 59883-720-08 Pro-Den Rx 1 in 1 CARTON RINSE 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59883-720 PRO-DEN RX (STANNOUS FLUORIDE) RINSE [DEN-MAT HOLDINGS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20231216_9036aa8a-59b1-41b0-b3cb-529d3303a1c0.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 39 of 50 · 995 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59883-720-08 59883072008 1 BOTTLE in 1 CARTON (59883-720-08) / 283.5 g in 1 BOTTLE 1 bottle 2008-10-31 0000-00-00 No No Current