FDA.reportPublic FDA data

SENSODYNE

Product NDC
0135-5022
Requested package NDC
0135-5022-01
11-digit product format
001355022
Labeler code
0135
Product ID
0135-5022_13128d65-3388-ef9b-e063-6394a90af6ff
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
2023-01-02
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 Gum and Enamel 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
d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5022-01SENSODYNESensitivity Gum and Enamel Mint1 in 1 CARTONPASTE14
0135-5022-01SENSODYNESensitivity Gum and Enamel Mint96.4 g in 1 TUBEPASTE96.44
0135-5022-02SENSODYNESensitivity Gum and Enamel Mint65.2 g in 1 TUBEPASTE65.24
0135-5022-02SENSODYNESensitivity Gum and Enamel Mint1 in 1 CARTONPASTE14
0135-5022-03SENSODYNESensitivity Gum and Enamel Mint2 in 1 CARTONPASTE24
0135-5022-03SENSODYNESensitivity Gum and Enamel Mint96.4 g in 1 TUBEPASTE96.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5022SENSODYNE SENSITIVITY GUM AND ENAMEL MINT (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 6 package rows20240308_d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2.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 35 of 39 · 774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro HealthCETYLPYRIDINIUM CHLORIDENavajo Manufacturing Company Inc.65bf17a9-21ad-27cb-e053-2991aa0afc402024-10-02WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening AdvancedPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC94e07979-943b-45bb-8e2b-90d686f3692e2024-09-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Advanced PlusPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC6eb304dd-2a24-4fa0-9d39-71264e88dd162024-08-29WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcfda7efa-86fa-470d-a79f-81907e31778a2024-08-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Bubble TwistSODIUM FLUORIDEHaleon US Holdings LLCe403529a-0fac-4dab-b75c-46906add096b2024-08-13WarningsExact identifier
application number: M022
Calcium Carbonate Assorted FlavorsANTACID TABLETSNuCare Pharmaceuticals,Inc.af10dfb6-fef3-3410-e053-2995a90a91302024-07-17WarningsExact identifier
application number: M022
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
application number: M022
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser SpearmintSODIUM PERBORATE MONOHYDRATEVintage Brands Limited7ac6c649-758f-4128-9920-466c0967b86a2024-05-21WarningsExact identifier
application number: M022
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
application number: M022
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
application number: M022
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-5022-01001355022011 TUBE in 1 CARTON (0135-5022-01) / 96.4 g in 1 TUBE1 tube2023-01-020000-00-00NoNoCurrent