FDA.reportPublic FDA data

Colgate Total SF Clean Mint

Product NDC
67751-224
11-digit product format
677510224
Labeler code
67751
Product ID
67751-224_2396613a-2015-0de0-e063-6394a90a9dff
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Navajo Manufacturing Company Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-01
Marketing end
2026-12-31
Substance
STANNOUS FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
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
Colgate Total SF Clean Mint

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
f71c53e0-e2dd-16f9-e053-6394a90accffAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-224-01Colgate Total SF Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
67751-224-01Colgate Total SF Clean Mint1 in 1 BLISTER PACKPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-224COLGATE TOTAL SF CLEAN MINT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 2 package rows20241004_f71c53e0-e2dd-16f9-e053-6394a90accff.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 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
application number: M022
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
application number: M022
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.b30e4b32-89dd-4e53-81d5-1415105361d42024-10-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEEfficient Laboratories Inc.28c5a993-fb5f-4091-af15-32ccae4b9a7d2024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive FreshmintPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.7e715bb9-666e-4de4-ba70-1c84f52434432024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.2daf18a3-f71e-4585-8128-4663eff7eb6d2024-10-14WarningsExact identifier
application number: M022
Anadent Kanka GelBENZOCAINEBELMORA LLCe0f73d78-5db1-43b4-8f58-e5410ca4560f2024-10-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
application number: M022
Colgate Great Regular FlavorSODIUM MONOFLUOROPHOSPHATENavajo Manufacturing Company Inc.f89bf259-b738-8229-e053-6394a90a0c592024-10-03WarningsExact identifier
application number: M022
Colgate Total SF Clean MintSTANNOUS FLUORIDENavajo Manufacturing Company Inc.f71c53e0-e2dd-16f9-e053-6394a90accff2024-10-03WarningsExact identifier
application number: M022
ndc (product): 67751-224
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf71c53e0-e2dd-16f9-e053-6394a90accff2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf71c53e0-e2dd-16f9-e053-6394a90accff2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf71c53e0-e2dd-16f9-e053-6394a90accff2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf71c53e0-e2dd-16f9-e053-6394a90accff2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf71c53e0-e2dd-16f9-e053-6394a90accff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-224-01677510224011 CARTON in 1 BLISTER PACK (67751-224-01) / 1 TUBE in 1 CARTON / 24.9 g in 1 TUBE1 carton2018-11-012026-12-31NoNoHistorical