Sensodyne

Product NDC
0135-4032
11-digit product format
001354032
Labeler code
0135
Product ID
0135-4032_445ed08a-b479-1982-e063-6394a90a6cc3
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate, sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-15
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.5 mg/g; 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
Cavity and Sensitivity
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d002074b-0580-4247-b3c7-121b8c098697Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-4032-01SensodyneCavity and Sensitivity1 in 1 CARTONPASTE, DENTIFRICE11
0135-4032-01SensodyneCavity and Sensitivity77 g in 1 TUBEPASTE, DENTIFRICE771

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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frida Fluoride Sweet MintSODIUM FLUORIDEFridababy, LLC4f8b5a39-5d79-72cd-e063-6394a90a475c2026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Bubble MintSODIUM FLUORIDEFridababy, LLC4f8b9af3-e4b3-b5e0-e063-6394a90a10682026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Strawberry Toothbrush SetSODIUM FLUORIDEFridababy, LLC4f8ba14f-60ea-c2a8-e063-6394a90a77022026-05-06WarningsExact identifier
application number: M021
Frida Fluoride StrawberrySODIUM FLUORIDEFridababy, LLC4f814a62-8f91-8ea6-e063-6294a90a69eb2026-05-06WarningsExact identifier
application number: M021
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsExact identifier
application number: M021
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
application number: M021
Crest 3D White Stain EraserSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.fdefffbd-9c05-fa30-e053-6394a90a34bc2026-05-05WarningsExact identifier
application number: M021
Frida Fluoride WatermelonSODIUM FLUORIDEFridababy, LLC4f8b49dc-e9e4-c341-e063-6294a90adb5a2026-05-05WarningsExact identifier
application number: M021
White Glo Extreme White WhiteningSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4a2e0a8d-420e-4c07-aa43-386d05dab4722026-04-30WarningsExact identifier
application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TPSTANNOUS FLUORIDEWalmart Inc.1e6561fb-4e3b-40ba-e063-6294a90a26902026-04-29WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.852889b4-59ba-4592-b4fc-c0127a1ad0752026-04-28WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus ScopeSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.0206710a-707f-4aa9-96b9-86240c1275dc2026-04-28WarningsExact identifier
application number: M021
Alcohol Free Refreshing MintSODIUM FLUORIDEH E Bcedf7c08-7412-4733-9b67-225b331cec8c2026-04-27Warnings, Adverse reactionsExact identifier
application number: M021
anzoon ANTIBACTERIAL MOUTH WASHCETYLPYRIDINIUM CHLORIDEShandong AZC Biotechnology Co.,Ltd.507c6896-2806-790c-e063-6394a90ac5ce2026-04-27WarningsExact identifier
application number: M021
DELTA COMFORT PLUS AMENITYSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.26434794-ae02-0f58-e063-6294a90ad85e2026-04-24WarningsExact identifier
application number: M021
A and H Plus Therabreath Breath FreshnersSODIUM FLUORIDEChurch & Dwight Co., Inc.18d6073e-b1ee-47d2-9758-2cf04f3cf3ca2026-04-23WarningsExact identifier
application number: M021
FluorideSODIUM FLUORIDEMcKesson5025e58e-e59c-07b6-e063-6394a90ac1e82026-04-23WarningsExact identifier
application number: M021
PRO-SYSSENSITIVITY - MINT (OTC)Benco Dental4e46847e-8c1d-c988-e063-6394a90a8e502026-04-22WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E B87327a36-a314-4daa-83b6-b4bd3e26bba22026-04-22Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E B8df324a7-9204-40f3-8ddb-1656286d7d4e2026-04-22Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNd002074b-0580-4247-b3c7-121b8c0986971
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDd002074b-0580-4247-b3c7-121b8c0986971
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYd002074b-0580-4247-b3c7-121b8c0986971
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYd002074b-0580-4247-b3c7-121b8c0986971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-4032-01001354032011 TUBE in 1 CARTON (0135-4032-01) / 77 g in 1 TUBE1 tube2025-12-15NoNoCurrent