FDA.reportPublic FDA data

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
IngredientStrength
STANNOUS FLUORIDE.63 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
583459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
152d84ee-d981-4032-bfb1-a559afe71d40Available on FDA.report

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QIONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OIONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0IONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EIONITE H (STANNOUS FLUORIDE) MOUTHWASH [DHARMA RESEARCH, INC.]1

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

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 6 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact identifier
application number: M021
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINTSODIUM FLUORIDEColgate-Palmolive Company9aaa451d-8827-41b7-9661-bc1a7a69cfc32026-06-30WarningsExact identifier
application number: M021

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