Ionite H

Product NDC
53045-275
11-digit product format
530450275
Labeler code
53045
Product ID
53045-275_48ad63b9-3911-40fe-8bd2-bcace77e5713
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ionite H
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.63 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui583459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-275-10Ionite H296 mL in 1 BOTTLE, DISPENSINGMOUTHWASH2962

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-275IONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]2Current NDC, Legacy NDC, 1 package rows20231012_5c312b36-07f4-406e-b3d3-c6d1e964635d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583459stannous fluoride 0.63 % Dental SolutionPSN5c312b36-07f4-406e-b3d3-c6d1e964635d2
583459stannous fluoride 6.3 MG/ML MouthwashSCD5c312b36-07f4-406e-b3d3-c6d1e964635d2
583459stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental SolutionSY5c312b36-07f4-406e-b3d3-c6d1e964635d2
583459stannous fluoride 0.63 % Dental SolutionSY5c312b36-07f4-406e-b3d3-c6d1e964635d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53045-275-1053045027510296 mL in 1 BOTTLE, DISPENSING (53045-275-10) 296 ml2015-08-030000-00-00NoNoCurrent