Home NDC 53045-276 Ionite H
Product NDC 53045-276
11-digit product format 530450276
Labeler code 53045
Product ID 53045-276_3e4113aa-0884-4a00-9492-47ce6242f3bc
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form MOUTHWASH
Route DENTAL
Labeler Dharma Research, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-08-03
Substance STANNOUS FLUORIDE
Active strength .63 mg/100mL
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 .63 mg/100mL
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 583459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53045-276-10 Ionite H 269 mL in 1 BOTTLE, DISPENSING MOUTHWASH 269 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-276 IONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231012_152d84ee-d981-4032-bfb1-a559afe71d40.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 53045-276-10 53045027610 269 mL in 1 BOTTLE, DISPENSING (53045-276-10) 269 ml 2015-08-03 0000-00-00 No No Current