Home NDC 55346-0408 Home Care Fluoride
Product NDC 55346-0408
11-digit product format 553460408
Labeler code 55346
Product ID 55346-0408_42c872dd-4a65-b88b-e063-6394a90aab20
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55346-0408-1 Home Care Fluoride 121.9 g in 1 TUBE GEL 121.9 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55346-0408 HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240207_c44686f8-93ee-4a8f-8481-3439d123f6d2.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 34 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dentisse SODIUM FLUORIDE Dentisse, Inc. 326b290a-9bd2-468e-e054-00144ff8d46c 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 51f1d84c-809a-4c96-a117-7a8d8aa1e6b4 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. c44686f8-93ee-4a8f-8481-3439d123f6d2 2025-11-04 Warnings Exact identifier application number: M021 ndc (product): 55346-0408 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 16ebcb37-5703-4e10-b965-570e18434b52 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker GREAT WHITE SHARK SODIUM FLUORIDE YOUNG PS ACQUISITION, LLC ca5b91aa-f69c-4553-a2b6-acf0ca1d920e 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65fa41e-ce2e-53e4-e053-2995a90a24d2 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65c62d9-e8a6-3101-e053-2995a90a1494 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75 2025-11-04 Warnings Exact identifier application number: M021 Strawberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426c2aca-ca2b-5e34-e063-6294a90ae37c 2025-11-02 Warnings Exact identifier application number: M021 Watermelon Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426e40cb-e30d-0db1-e063-6294a90a762b 2025-10-31 Warnings Exact identifier application number: M021 Classic Mint Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425a9b71-5a7f-83e6-e063-6394a90ab703 2025-10-30 Warnings Exact identifier application number: M021 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425b1a2e-7576-13a7-e063-6394a90aa865 2025-10-30 Warnings Exact identifier application number: M021 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426b8efa-e691-a67d-e063-6394a90abf8d 2025-10-30 Warnings Exact identifier application number: M021 Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 42583b32-525f-925d-e063-6294a90af76f 2025-10-29 Warnings Exact identifier application number: M021 PERIOE KAKAO KIDS Strawberry SODIUM FLUORIDE LG HOUSEHOLD & HEALTH CARE LTD. 4239f8c2-a5f5-3fa6-e063-6294a90acb47 2025-10-28 Warnings Exact identifier application number: M021 Gerigentle-Good morning SODIUM FLORIDE Geri-Gentle Corporation e69b3767-00c5-a535-e053-2995a90ad215 2025-10-23 Warnings Exact identifier application number: M021 Hello Penguin Chill SODIUM FLUORIDE Colgate-Palmolive Company 5c47a7d5-da34-4658-8006-b36f6477cb9b 2025-10-23 Warnings Exact identifier application number: M021 Auraglow Whitening SODIUM FLUORIDE Auraglow LLC 9d45e436-92f6-4a9e-9b82-329847dca9ba 2025-10-22 Warnings Exact identifier application number: M021 COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3 2025-10-21 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Qubec Inc. DBA Attitude de21b326-f885-464b-b2df-f3866a0b3e9a 2025-10-20 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55346-0408-1 55346040801 121.9 g in 1 TUBE (55346-0408-1) 121.9 g 1999-12-31 0000-00-00 No No Current