Home NDC 59883-004 Fluoridex
Product NDC 59883-004
11-digit product format 598830004
Labeler code 59883
Product ID 59883-004_0a96438c-733f-8bce-e063-6394a90a0ce7
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride Rinse
Dosage form LIQUID
Route ORAL
Labeler DEN-MAT HOLDINGS, LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-11
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 Fluoridex
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 59883-004-01 Fluoridex 310 g in 1 BOTTLE, PLASTIC LIQUID 310 3 59883-004-01 Fluoridex 1 in 1 BOX LIQUID 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59883-004 FLUORIDEX (STANNOUS FLUORIDE RINSE) LIQUID [DEN-MAT HOLDINGS, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231216_5e81f073-c0ca-aa38-e053-2a91aa0ab37b.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 50 · 995 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59883-004-01 59883000401 1 BOTTLE, PLASTIC in 1 BOX (59883-004-01) / 310 g in 1 BOTTLE, PLASTIC 2016-01-11 0000-00-00 No No Current