FDA.reportPublic FDA data

SENSODYNE

Product NDC
0135-5024
11-digit product format
001355024
Labeler code
0135
Product ID
0135-5024_13123f95-ce72-c317-e063-6394a90ac2d2
Type
HUMAN OTC DRUG
Nonproprietary name
stannous fluoride
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-06
Substance
STANNOUS FLUORIDE
Active strength
1.1 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
Sensitivity and Gum Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.1 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
ed093acd-255c-40ff-a010-d276f5844453Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5024-01SENSODYNESensitivity and Gum Whitening1 in 1 CARTONPASTE16
0135-5024-01SENSODYNESensitivity and Gum Whitening96.4 g in 1 TUBEPASTE96.46
0135-5024-02SENSODYNESensitivity and Gum Whitening65.2 g in 1 TUBEPASTE65.26
0135-5024-02SENSODYNESensitivity and Gum Whitening1 in 1 CARTONPASTE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5024SENSODYNE SENSITIVITY AND GUM MINT (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM WHITENING (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20240308_ed093acd-255c-40ff-a010-d276f5844453.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 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
application number: M022
parodontax Active Gum RepairSTANNOUS FLUORIDEHaleon US Holdings LLCb51ccdd9-c0af-4caa-ad97-ad1d1423b76b2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLC59bb84d6-6fd3-4586-bccf-7dc45cbbb39c2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
application number: M022
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
application number: M022
R B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.410c40fd-cf94-0301-e063-6294a90ae2de2025-12-18WarningsExact identifier
application number: M022
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
application number: M022
Res B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.21469f58-1d70-774f-e063-6294a90af0392025-12-18WarningsExact identifier
application number: M022
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
application number: M022
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
application number: M022
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.c13761e0-d45d-4e0f-ac41-428e005f96bb2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.6dca566b-cb6a-43c4-b6e2-f2bad77fb9322025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.7ede08e5-2dfe-4183-905d-28d1cea424072025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.9de36e4f-f966-4a58-b4bf-9ac3b86b3f092025-12-17WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDECVS PHARMACY, INC3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb22025-12-17WarningsExact identifier
application number: M022
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYed093acd-255c-40ff-a010-d276f58444536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-5024-01001355024011 TUBE in 1 CARTON (0135-5024-01) / 96.4 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-5024-02001355024021 TUBE in 1 CARTON (0135-5024-02) / 65.2 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent