Home NDC 59883-404 kids kare
Product NDC 59883-404
11-digit product format 598830404
Labeler code 59883
Product ID 59883-404_2a998081-6425-8228-e063-6294a90adc3d
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form GEL
Route DENTAL; ORAL
Labeler DEN-MAT HOLDINGS, LLC.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-12
Substance STANNOUS FLUORIDE
Active strength .969 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 kids kare
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .969 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59883-404-04 kids kare 121.9 g in 1 TUBE GEL 121.9 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59883-404 KIDS KARE (STANNOUS FLUORIDE) GEL [DEN-MAT HOLDINGS, LLC.] 4 Current NDC, Legacy NDC, 1 package rows 20250102_66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91.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 5 of 51 · 1,013 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 59883-404-04 59883040404 121.9 g in 1 TUBE (59883-404-04) 121.9 g 2017-10-12 0000-00-00 No No Current