FDA.reportPublic FDA data

SENSODYNE

Product NDC
0135-5023
11-digit product format
001355023
Labeler code
0135
Product ID
0135-5023_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

Additional Listing Data#

Finished product
Yes
Brand name base
SENSODYNE
Brand name suffix
Sensitivity and Gum Mint
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
0135-5023-01SENSODYNESensitivity and Gum Mint1 in 1 CARTONPASTE16
0135-5023-01SENSODYNESensitivity and Gum Mint96.4 g in 1 TUBEPASTE96.46
0135-5023-02SENSODYNESensitivity and Gum Mint23 g in 1 TUBEPASTE236
0135-5023-02SENSODYNESensitivity and Gum Mint1 in 1 CARTONPASTE16
0135-5023-03SENSODYNESensitivity and Gum Mint23 g in 1 TUBEPASTE236
0135-5023-04SENSODYNESensitivity and Gum Mint96.4 g in 1 TUBEPASTE96.46
0135-5023-04SENSODYNESensitivity and Gum Mint3 in 1 CARTONPASTE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5023SENSODYNE 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, 7 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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
Made by Dentists Enamel 10 Fluoride AnticavityPOTASSIUM NITRATE, SODIUM FLUORIDEMade By Dentists Inc3c62eab1-0cb6-4bdf-bfd4-c5afe734d0362026-07-24WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-07-06WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-07-03WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact 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
0135-5023-01001355023011 TUBE in 1 CARTON (0135-5023-01) / 96.4 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-5023-02001355023021 TUBE in 1 CARTON (0135-5023-02) / 23 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-5023-030013550230323 g in 1 TUBE (0135-5023-03) 23 g2023-01-020000-00-00NoNoCurrent
0135-5023-04001355023043 TUBE in 1 CARTON (0135-5023-04) / 96.4 g in 1 TUBE3 tube2024-01-02NoNoCurrent