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 33 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag229a7feb-c646-4557-85e5-0832682ab9262024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag0e135eb0-4a40-4930-ade4-fb7df87db1f42024-12-05WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola Ag73d767e2-bb80-4eff-8420-500c2a4067aa2024-12-05WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola Ag951e9836-e6a3-4094-8a6b-f226c85c897a2024-12-05WarningsExact identifier
application number: M022
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag67373cf1-e8c3-4db2-98e1-c88d25a762092024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag586b2a46-2673-4f27-a62a-2d48a9b520ab2024-12-05WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola Aga2bdd035-4678-4cff-b24f-8e2f06acad962024-12-05WarningsExact identifier
application number: M022
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore RinseHYDROGEN PEROXIDE, MENTHOLChurch & Dwight Co., Inc.99d47d6a-fa2e-d5ee-e053-2995a90aa11d2024-11-27WarningsExact identifier
application number: M022
Orajel 2x Gum Pain Alcohol-FreeMENTHOL AND HYDROGEN PEROXIDEChurch & Dwight Co., Inc.adf37010-922c-4441-93d6-1e1a95025e902024-11-27WarningsExact identifier
application number: M022
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
application number: M022
Peroxyl Mouth Sore Mild MintHYDROGEN PEROXIDEColgate Oral Pharmaceuticals Inc.b1e1b7c9-dea7-4d64-b6a8-5343f41763592024-11-25WarningsExact identifier
application number: M022
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
application number: M022
TANAC Oral Pain RelieverBENZOCAINELeosons Overseas Corp81cc61fa-31a7-2214-e053-2a91aa0ae46a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT Honey LemonPHENOLLeosons Overseas Corp601aea98-e6ab-de6f-e053-2a91aa0a824a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT CherryPHENOLLeosons Overseas Corp5f21694c-d1c9-0e64-e053-2a91aa0a0ff02024-11-15WarningsExact identifier
application number: M022
Sore ThroatPHENOLSafeway, Inc.f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d2024-11-14WarningsExact identifier
application number: M022
Sore Throat Relief CherryPHENOLBest Choice (Valu Merchandisers Company)c0a47d59-3e15-453d-97a7-d626e86508622024-11-14WarningsExact 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