Home NDC 53045-280 Ionite H
Product NDC 53045-280
11-digit product format 530450280
Labeler code 53045
Product ID 53045-280_0b21c890-82f5-4e90-8aa1-1e06d631760e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride, Potassium Nitrate
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Dharma Research, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2015-08-02
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength 1.1; 5 mg/100g; mg/100g
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 Ionite H
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/100g POTASSIUM NITRATE 5 mg/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 637365 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 53045-280-04 Ionite H 122 g in 1 TUBE GEL, DENTIFRICE 122 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 NITRATE ION ACTIVE MOIETY T93E9Y2844 IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 EDETIC ACID INACTIVE INGREDIENT 9G34HU7RV0 IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 SODIUM POLYMETAPHOSPHATE INACTIVE INGREDIENT P1BM4ZH95L IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 TRICALCIUM PHOSPHATE INACTIVE INGREDIENT K4C08XP666 IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-280 IONITE H (SODIUM FLUORIDE, POTASSIUM NITRATE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20150803_54c1a27c-5936-4ee2-a419-3891d3df9745.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ionite H SODIUM FLUORIDE, POTASSIUM NITRATE Dharma Research, Inc. 54c1a27c-5936-4ee2-a419-3891d3df9745 2015-08-02 Warnings, Adverse reactions Exact identifier ndc (product): 53045-280
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 53045-280-04 53045028004 122 g in 1 TUBE (53045-280-04) 122 g 2015-08-02 0000-00-00 No No Current