FDA.reportPublic FDA data

Colgate Sensitive plus Whitening

Product NDC
35000-023
11-digit product format
350000023
Labeler code
35000
Product ID
35000-023_a0bc4e50-643e-47cb-a47f-b3978c197387
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-25
Marketing end
2027-12-31
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; 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 Sensitive plus Whitening

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.1 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
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2092c747-e025-47a9-9e54-731631d3c831Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-023-34Colgate Sensitive plus Whitening2 in 1 CARTONPASTE, DENTIFRICE28
35000-023-34Colgate Sensitive plus Whitening170 g in 1 TUBEPASTE, DENTIFRICE1708
35000-023-46Colgate Sensitive plus Whitening130 g in 1 TUBEPASTE, DENTIFRICE1308
35000-023-46Colgate Sensitive plus Whitening1 in 1 CARTONPASTE, DENTIFRICE18
35000-023-60Colgate Sensitive plus Whitening1 in 1 CARTONPASTE, DENTIFRICE18
35000-023-60Colgate Sensitive plus Whitening170 g in 1 TUBEPASTE, DENTIFRICE1708

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-023COLGATE SENSITIVE PLUS WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]7Current NDC, Legacy NDC, 6 package rows20240113_2092c747-e025-47a9-9e54-731631d3c831.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 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2092c747-e025-47a9-9e54-731631d3c8318
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-023-34350000023342 TUBE in 1 CARTON (35000-023-34) / 170 g in 1 TUBE2 tube2019-02-252027-12-31NoNoCurrent
35000-023-46350000023461 TUBE in 1 CARTON (35000-023-46) / 130 g in 1 TUBE1 tube2020-06-152027-12-31NoNoCurrent
35000-023-60350000023601 TUBE in 1 CARTON (35000-023-60) / 170 g in 1 TUBE1 tube2019-02-252027-12-31NoNoCurrent