Home NDC 59883-718 Kids Kare
Product NDC 59883-718
11-digit product format 598830718
Labeler code 59883
Product ID 59883-718_2a9ae6d7-048d-3bd5-e063-6394a90a651e
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL; ORAL
Labeler DEN-MAT HOLDINGS, LLC.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-26
Substance SODIUM FLUORIDE
Active strength 2.4 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 SODIUM FLUORIDE 2.4 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 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 59883-718-04 Kids Kare 113.4 g in 1 TUBE PASTE, DENTIFRICE 113.4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59883-718 KIDS KARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [DEN-MAT HOLDINGS, LLC.] 3 Current NDC, Legacy NDC, 1 package rows 20250102_66d6b20f-d0ff-4dfe-e053-2991aa0a99ca.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 6 of 50 · 995 matching rows.
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 59883-718-04 59883071804 113.4 g in 1 TUBE (59883-718-04) 113.4 g 2017-10-26 0000-00-00 No No Current