FDA.reportPublic FDA data

Ionite H

Product NDC
53045-271
11-digit product format
530450271
Labeler code
53045
Product ID
53045-271_91060eb1-2d2e-4100-912f-05e7b46c9ae3
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Dharma Research, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-02
Substance
STANNOUS FLUORIDE
Active strength
.4 mg/100g
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.4 mg/100g

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
237847Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
042636cf-8b61-4022-b0a1-af09c06b145bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53045-271-04Ionite H122 g in 1 TUBEGEL, DENTIFRICE1222

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EIONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-271IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]2Current NDC, Legacy NDC, 1 package rows20231012_042636cf-8b61-4022-b0a1-af09c06b145b.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
ndc (product): 53045-271
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237847stannous fluoride 0.4 % Oral GelPSN042636cf-8b61-4022-b0a1-af09c06b145b2
237847stannous fluoride 0.004 MG/MG Oral GelSCD042636cf-8b61-4022-b0a1-af09c06b145b2
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY042636cf-8b61-4022-b0a1-af09c06b145b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53045-271-0453045027104122 g in 1 TUBE (53045-271-04) 122 g2015-08-020000-00-00NoNoCurrent