Home NDC 55346-0401 Home Care Fluoride
Product NDC 55346-0401
11-digit product format 553460401
Labeler code 55346
Product ID 55346-0401_42c8aa46-9e15-ec47-e063-6294a90a06c3
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
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55346-0401-2 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55346-0401-2 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55346-0401-2 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55346-0401-2 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55346-0401-2 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55346-0401-2 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55346-0401-2 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55346-0401-2 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55346-0401-2 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55346-0401-2 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55346-0401-2 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55346-0401-2 557ba5c1ecfa…9c80585c8c6e…
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 55346-0401-1 Home Care Fluoride 121.9 g in 1 TUBE GEL 121.9 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55346-0401 HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240207_15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75.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 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hello Whipped Mellow Mint Dream Flavor SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company 7a72b687-475d-437a-9734-a29637e5516a 2025-11-11 Warnings Exact identifier application number: M021 Spry Dentifrice TOOTHPASTE Xlear Inc. 43567bbc-b07e-b605-e063-6294a90aad78 2025-11-11 Warnings Exact identifier application number: M021 Hello Naturally Whitening SODIUM MONOFLUOROPHOSPHATE COLGATE PALMOLIVE COMPANY 5ad241e1-6bfc-7863-6a7a-100753651f0a 2025-11-11 Warnings Exact identifier application number: M021 Hello Whipped Peppermint Stick Flavor SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company d6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f813 2025-11-11 Warnings Exact identifier application number: M021 Super Mint MINT TOOTHPASTE SuperMouth, LLC. d23e89f5-7b65-4ed9-803a-38233f30d8f2 2025-11-07 Warnings Exact identifier application number: M021 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 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 ndc (product): 55346-0401 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55346-0401-1 55346040101 121.9 g in 1 TUBE (55346-0401-1) 121.9 g 1999-12-31 0000-00-00 No No Current