FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-5912
11-digit product format
001355912
Labeler code
0135
Product ID
0135-5912_401f46e0-14e4-a791-e063-6394a90aeb56
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
STANNOUS FLUORIDE
Active strength
15 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
Sensodyne
Brand name suffix
Fresh Clean
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE15 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d433ac1-3ddf-a2f4-e063-6394a90a91f8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5912-01SensodyneFresh Clean23 g in 1 TUBEPASTE, DENTIFRICE232
0135-5912-01SensodyneFresh Clean1 in 1 CARTONPASTE, DENTIFRICE12
0135-5912-02SensodyneFresh Clean1 in 1 CARTONPASTE, DENTIFRICE12
0135-5912-02SensodyneFresh Clean65 g in 1 TUBEPASTE, DENTIFRICE652
0135-5912-03SensodyneFresh Clean96 g in 1 TUBEPASTE, DENTIFRICE962
0135-5912-03SensodyneFresh Clean1 in 1 CARTONPASTE, DENTIFRICE12

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 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Mint JulepGINGICAINE GEL, MINT JULEP FLABVORGingi-Pak a Division of the Belport6285fe10-08ba-8044-e053-2991aa0a8e8b2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2d433ac1-3ddf-a2f4-e063-6394a90a91f82
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2d433ac1-3ddf-a2f4-e063-6394a90a91f82
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2d433ac1-3ddf-a2f4-e063-6394a90a91f82
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2d433ac1-3ddf-a2f4-e063-6394a90a91f82
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2d433ac1-3ddf-a2f4-e063-6394a90a91f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-5912-01001355912011 TUBE in 1 CARTON (0135-5912-01) / 23 g in 1 TUBE1 tube2025-12-01NoNoCurrent
0135-5912-02001355912021 TUBE in 1 CARTON (0135-5912-02) / 65 g in 1 TUBE1 tube2025-12-01NoNoCurrent
0135-5912-03001355912031 TUBE in 1 CARTON (0135-5912-03) / 96 g in 1 TUBE1 tube2025-12-01NoNoCurrent