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 5 of 50 · 995 matching rows.
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