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 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 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
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