FDA.reportPublic FDA data

Home Care Fluoride

Product NDC
55346-0404
11-digit product format
553460404
Labeler code
55346
Product ID
55346-0404_42c873be-f572-d9df-e063-6394a90a16b4
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL
Route
DENTAL; ORAL
Labeler
Dental Technologies, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1999-12-31
Substance
STANNOUS FLUORIDE
Active strength
.969 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Home Care Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.969 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16ebcb37-5703-4e10-b965-570e18434b52Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-0404-1Home Care Fluoride121.9 g in 1 TUBEGEL121.912

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QHOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7
FLUORIDE IONACTIVE MOIETYQ80VPU408OHOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RHOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7
CARBOMER 934INACTIVE INGREDIENTZ135WT9208HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKHOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-0404HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]11Current NDC, Legacy NDC, 1 package rows20240207_16ebcb37-5703-4e10-b965-570e18434b52.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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINTSODIUM FLUORIDETom's of Maine, Inc.b9e6e455-8444-4805-89f1-ee9142f98e362026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.7db8e49d-1073-4a81-a3a4-f3a19ebce9212026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINTSODIUM FLUORIDETom's of Maine, Inc.1fe50b49-bc62-4137-866c-e87bb878a96d2026-08-10WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55346-0404-155346040401121.9 g in 1 TUBE (55346-0404-1) 121.9 g1999-12-310000-00-00NoNoCurrent