Home NDC 53045-271 Ionite H
Product NDC 53045-271
11-digit product format 530450271
Labeler code 53045
Product ID 53045-271_91060eb1-2d2e-4100-912f-05e7b46c9ae3
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Dharma Research, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-08-02
Substance STANNOUS FLUORIDE
Active strength .4 mg/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Ionite H
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .4 mg/100g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53045-271-04 Ionite H 122 g in 1 TUBE GEL, DENTIFRICE 122 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded STANNOUS FLUORIDE ACTIVE INGREDIENT 3FTR44B32Q IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-271 IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231012_042636cf-8b61-4022-b0a1-af09c06b145b.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 46 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor SODIUM FLUORIDE Ashtel Studios Inc. bbf6cfe7-c5e5-4e63-ac7d-4535a0ca3973 2024-07-31 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 32780fe9-82bf-42f8-8218-bed5bc579c72 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 7ba8cff2-92a4-4432-aaf3-50358d9483a2 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ed057c95-90cd-4edb-ac00-78db8f6a065b 2024-07-29 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. f01c5eaf-7e81-4b30-bb6f-50566a727364 2024-07-29 Warnings Exact identifier application number: M021 Sodium Monofluorophosphate WHITE TOOTHPASTE Dynarex Corporation 1be422b9-6320-ed5c-e063-6294a90a7e42 2024-07-03 Warnings Exact identifier application number: M021 Wpgcng Antiacvity Fluoride Mouthwash SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 5756206e-43cc-8cc7-e063-6394a90a2950 2024-07-03 Warnings Exact identifier application number: M021 dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum SODIUM FLUORIDE Lidl US, LLC 0c77ba33-acb9-4c83-aa75-7d5c82f903eb 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE WHITENING MINT SODIUM FLUORIDE Lidl US, LLC 37011052-16ef-4ae4-aade-a86f9fa9cdac 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Lidl US, LLC ccf54743-81c2-43f8-9c5c-d4baa85fc18d 2024-07-02 Warnings Exact identifier application number: M021 SmileSense STANNOUS FLUORIDE SGII, INC 1c371393-da75-c9c8-e063-6294a90a5840 2024-07-01 Warnings Exact identifier application number: M021 Sodium Fluoride CLEAR MINT, GEL TOOTHPASTE Dynarex Corporation 1be193b6-4c07-4f0a-e063-6394a90a32c7 2024-06-27 Warnings Exact identifier application number: M021 CREST CAVITY PROTECTION COOL MINT SODIUM FLUORIDE A-S Medication Solutions dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d 2024-06-12 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. a37e9d9c-dca9-4d58-a716-4514ebe8ec88 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 0e6b01a4-1132-489f-936c-d3a54e9e21e0 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ffb8c43c-8f45-42ec-83eb-f0c83f7f99f8 2024-06-11 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 1a26ad70-9773-dc4f-e063-6294a90ac333 2024-05-31 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE LG H&H Co.,Ltd. 1a01481f-3e02-634e-e063-6394a90ac5fc 2024-05-31 Warnings Exact identifier application number: M021 Brush Buddies - Hot Wheels ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios Inc. 86dd5e9c-71c3-46ce-ae4c-45d19468667d 2024-05-29 Warnings Exact identifier application number: M021 Dentalclean Doctor Duck Kids Flouride Mouthwash SODIUM FLUORIDE 0.02% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 18806738-82fa-1a37-e063-6294a90a3888 2024-05-15 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 53045-271-04 53045027104 122 g in 1 TUBE (53045-271-04) 122 g 2015-08-02 0000-00-00 No No Current