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 42 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05a9cee1-bd6e-6b93-e063-6294a90a5c102025-01-01WarningsExact identifier
application number: M021
PERIOE POP Advanced Whitening Prebiotic Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f546470a-7fae-4988-e053-2995a90ab61b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Whitening Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de97dbea-dc8c-ebfa-e053-2995a90a22702025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b1020b-a1c3-e1eb-e063-6394a90ac2662025-01-01WarningsExact identifier
application number: M021
PERIOE POP Complete Protection Prebiotic Mint BlastSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f547a468-d2fd-7176-e053-2995a90a55392025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.b4530d56-3a17-6868-e053-2995a90a25242025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Total Care Strong MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de996aeb-9ac0-836f-e053-2a95a90aeda62025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05aafc53-49ca-eacd-e063-6394a90a606b2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b18bb6-9fbf-469b-e063-6294a90a4f2f2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.9c820740-9148-3a9c-e053-2a95a90a39682025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials Fresh Aloe Green MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.a3b21ceb-5aa5-29b4-e053-2a95a90a95452025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDELG H&H Co., Ltd.05b25897-460c-2dfb-e063-6294a90ada3b2025-01-01WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H Co., Ltd.05b1f105-6f75-7a45-e063-6394a90a58bc2025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDELG H&H Co., Ltd.05b25083-12f3-7a85-e063-6394a90a492e2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDELG H&H Co., Ltd.05b276a1-3778-104d-e063-6294a90a75372025-01-01WarningsExact identifier
application number: M021
kids kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
application number: M021
Kids KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
application number: M021
Morning FreshSODIUM FLUORIDEDynarex Corporation1d0457d7-0228-4ea3-9755-73bacd2201e62024-12-27WarningsExact identifier
application number: M021
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact 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