Home NDC 68400-201 Gelato Homecare
Product NDC 68400-201
11-digit product format 684000201
Labeler code 68400
Product ID 68400-201_1679a47c-dc75-72ca-e063-6294a90a39c0
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form GEL
Route DENTAL
Labeler Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-05
Substance STANNOUS FLUORIDE
Active strength .116 g/120g
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 Gelato Homecare
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .116 g/120g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237847 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 68400-201-04 Gelato Homecare 120 g in 1 TUBE GEL 120 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Stannous Fluoride ACTIVE INGREDIENT 3FTR44B32Q GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 Fluoride Ion ACTIVE MOIETY Q80VPU408O GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 Malic Acid INACTIVE INGREDIENT 817L1N4CKP GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-201 GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 7 Current NDC, Legacy NDC, 1 package rows 20240426_1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db.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 19 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burts Bees Charcoal Peppermint SODIUM FLUORIDE Procter & Gamble Manufacturing Company a343853e-4968-2753-e053-2995a90ab152 2026-02-02 Warnings Exact identifier application number: M021 Burts Bees Complete Multi-Care SODIUM FLUORIDE Procter & Gamble Manufacturing Company 12615266-06e8-b891-e063-6394a90ad75d 2026-02-02 Warnings Exact identifier application number: M021 LIVFRESH GUM PROTECT STANNOUS FLUORIDE Livionex Inc. 1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Disney Cars Chow Cherry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d66ad5-cdae-52f4-e063-6294a90a8ee9 2026-02-01 Warnings Exact identifier application number: M021 Crest 3D White Deep Stain Remover Brilliant White SODIUM MONOFLUOROPHOSPHATE The Procter & Gamble Manufacturing Company 4e53a086-6cda-6460-e063-6394a90af1f3 2026-02-01 Exact identifier application number: M021 ACT Kids Berry Blast SODIUM FLUORIDE Chattem, Inc. 4f81ea98-5c74-4473-9764-3f11d627cdf1 2026-02-01 Warnings Exact identifier application number: M021 Anticavity Rinse SODIUM FLUORIDE Rite Aid Corporation c1a22692-b955-498a-a7c1-1cd7bfd54bda 2026-01-30 Warnings, Adverse reactions Exact identifier application number: M021 ARU GUM HEALTH STANNOUS FLUORIDE Ashtel Studios, Inc. d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd3 2026-01-30 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED b5eec445-d93a-4abb-a5e3-bfcde6fa2013 2026-01-28 Warnings Exact identifier application number: M021 Supersmile Original Mint SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 24fee793-57ed-87e9-e063-6394a90ab4ce 2026-01-28 Warnings Exact identifier application number: M021 Colgate 5g and Toothbrush Dental Kit SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED 0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey Punch SODIUM FLUORIDE Ashtel Studios Inc. 023cb63c-52b4-4723-bff6-c25105a53f76 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike Strawberry SODIUM FLUORIDE Ashtel Studios, Inc. ef4ea4a3-c1ac-447f-a70b-e3a330928cfd 2026-01-27 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Tom's of Maine ae6de376-76fd-4609-a2d5-7a902c0d4c5c 2026-01-27 Warnings Exact identifier application number: M021 Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum) SODIUM FLUORIDE Made by Dentists Inc. f3f6b32d-8e47-4f52-bd9a-20bd51c9d007 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape SODIUM FLUORIDE Ashtel Studios Inc. 6c6d143f-4c2b-4207-bde7-9df8251616a3 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELON SODIUM FLUORIDE Ashtel Studios, Inc. d80d0a87-5d1f-4114-977a-036ffed77205 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard Berry SODIUM FLUORIDE Ashtel Studios, Inc. ac18dd0a-d476-48a7-8493-594a0293b926 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRY SODIUM FLUORIDE Ashtel Studios, Inc. 2500e14e-6cf4-4ac4-810f-1ef163c5e474 2026-01-27 Warnings Exact identifier application number: M021 Hello Unicorn Splash SODIUM FLUORIDE Accupac LLC 23807810-990a-b723-e063-6394a90aee3e 2026-01-22 Warnings Exact identifier application number: M021
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 68400-201-04 68400020104 120 g in 1 TUBE (68400-201-04) 120 g 2016-09-01 0000-00-00 No No Current