Home NDC 55346-0404 Home Care Fluoride
Product NDC 55346-0404
11-digit product format 553460404
Labeler code 55346
Product ID 55346-0404_42c873be-f572-d9df-e063-6394a90a16b4
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form GEL
Route DENTAL; ORAL
Labeler Dental Technologies, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 1999-12-31
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 Home Care Fluoride
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 55346-0404-1 Home Care Fluoride 121.9 g in 1 TUBE GEL 121.9 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55346-0404 HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20240207_16ebcb37-5703-4e10-b965-570e18434b52.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 Units Marketing start Marketing end Sample Exclude flag Status 55346-0404-1 55346040401 121.9 g in 1 TUBE (55346-0404-1) 121.9 g 1999-12-31 0000-00-00 No No Current