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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53045-276-102021-02-17C16284748780-1ba0f9c33-4050-a910-e053-dadaa90a0b85152d84ee-d981-4032-bfb1-a559afe71d40
53045-276-102021-01-29C16284748780-1ba0f9c33-4050-a910-e053-dadaa90a0b85152d84ee-d981-4032-bfb1-a559afe71d40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-276-10Ionite H269 mL in 1 BOTTLE, DISPENSINGMOUTHWASH2693

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-276IONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]3Current NDC, Legacy NDC, 1 package rows20231012_152d84ee-d981-4032-bfb1-a559afe71d40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583459stannous fluoride 0.63 % Dental SolutionPSN152d84ee-d981-4032-bfb1-a559afe71d403
583459stannous fluoride 6.3 MG/ML MouthwashSCD152d84ee-d981-4032-bfb1-a559afe71d403
583459stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental SolutionSY152d84ee-d981-4032-bfb1-a559afe71d403
583459stannous fluoride 0.63 % Dental SolutionSY152d84ee-d981-4032-bfb1-a559afe71d403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53045-276-1053045027610269 mL in 1 BOTTLE, DISPENSING (53045-276-10) 269 ml2015-08-030000-00-00NoNoCurrent