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 31 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba491f4-2ad2-6e7b-e063-6394a90a9fb7 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188ac743-3ba8-4da4-e063-6294a90a8f87 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b682604-c563-01f1-e063-6294a90ab0bd 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b110db1-fcc0-377f-e063-6394a90a4d44 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74ecc4-a1e6-348f-e063-6294a90a5894 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b68315c-6afa-3f37-e063-6294a90a14e8 2025-12-11 Warnings Exact identifier application number: M021 ANTICAVITY FLUORIDE SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 295b88e8-c4b5-c0b0-e063-6394a90aca01 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74f072-c33b-c6e2-e063-6394a90ab1e6 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba4a807-d6d5-04a0-e063-6294a90ae04d 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b617f4a-b56c-9f75-e063-6294a90a7abe 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b9ec370-eadf-92c4-e063-6294a90a9055 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1eb04296-ecb1-3ccc-e063-6294a90a9bda 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b9e7b21-0d34-74ec-e063-6294a90a1f59 2025-12-11 Exact identifier application number: M021 Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash SODIUM FLUORIDE Kenvue Brands LLC 28986d7f-3e9a-8dfb-e063-6394a90a731e 2025-12-10 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Colgate-Palmolive Company 0d6c51bc-5391-4533-b4fd-961dc4f36342 2025-12-10 Warnings Exact identifier application number: M021 Business Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. 483d7aec-34ac-49c5-ac0e-8fba5b4737ae 2025-12-09 Warnings Exact identifier application number: M021 Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 121decce-c364-4060-87da-0c6a6cd48474 2025-12-08 Warnings Exact identifier application number: M021 First Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. ba717de8-c3a2-41bf-85a1-aa75f9744d30 2025-12-08 Warnings Exact identifier application number: M021 United Airlines Business Class Kit SODIUM MONOFLUOROPHOSPHATE United Airlines 94c5e9a4-19f3-4590-9da4-313c75261231 2025-12-08 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 5f08d994-e458-42b2-aa39-e84fca3acf48 2025-12-05 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