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
Ingredient	Strength
STANNOUS FLUORIDE	.4 mg/100g

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
237847	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
042636cf-8b61-4022-b0a1-af09c06b145b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53045-271-04	Ionite H	122 g in 1 TUBE	GEL, DENTIFRICE	122		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53045-271	IONITE H (STANNOUS FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20231012_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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toms of Maine Whiten Plus Deep Clean Peppermint	SODIUM FLUORIDE	Tom's of Maine	4c535776-3f80-4eeb-bb63-2d734c3c3a6b	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	dd6bf8df-1e28-4f61-b876-b9f1f8d5993a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	8283cea0-7b62-4796-8763-6654039664cd	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	9d055fed-26d8-4827-a4cc-8c314514a6c3	2026-02-17	Warnings	Exact identifier application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	28d1b8c3-930f-4ac9-aa5a-b72b832bb77e	2026-02-17	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	088b95e6-30fd-4263-9fdc-57cd63385b71	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	e31c1609-a1c3-4ed5-adfd-3cfa63205ec3	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	3602c528-5f53-4d41-bf67-163149f52b35	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	e696038c-182e-4325-9b90-87fe498d9f67	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	3b04142a-4a65-45ba-a5a2-e62b0c47ec55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Topco Associates LLC	c640adc0-e178-4b6a-af44-07d2f7da81d3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Topco Associates LLC	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Topco Associates LLC	84b30711-a7e5-4189-895a-a7989f05591c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Topco Associates LLC	c3f2e952-a8d5-4e9d-a5c6-09e4f2544179	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Topco Associates LLC	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Salivea	FLUORIDE TOOTHPASTE	Laclede, Inc.	4abb0f80-d87d-730f-e063-6294a90a15f7	2026-02-13	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	581d5cdb-018a-42ad-899d-5331f0063376	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Your Military Exchanges	965911c3-7aa8-4830-8269-6aa5d526ee73	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237847	stannous fluoride 0.4 % Oral Gel	PSN	042636cf-8b61-4022-b0a1-af09c06b145b	2
237847	stannous fluoride 0.004 MG/MG Oral Gel	SCD	042636cf-8b61-4022-b0a1-af09c06b145b	2
237847	stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel	SY	042636cf-8b61-4022-b0a1-af09c06b145b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53045-271-04	53045027104	122 g in 1 TUBE (53045-271-04)	122 g	2015-08-02	0000-00-00	No	No	Current