FDA.reportPublic FDA data

Colgate Optic White Stain Fighter Sens Relief

Product NDC
35000-998
11-digit product format
350000998
Labeler code
35000
Product ID
35000-998_53744624-454a-4b7a-b87b-08ea33e238aa
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-01
Marketing end
2027-11-01
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
1.5; 50 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 Optic White Stain Fighter Sens Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g
POTASSIUM NITRATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal 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
6ec2fff7-df44-4302-be2d-97946c6cd66aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-998-60Colgate Optic White Stain Fighter Sens Relief1 in 1 CARTONPASTE, DENTIFRICE18
35000-998-60Colgate Optic White Stain Fighter Sens Relief85 g in 1 TUBEPASTE, DENTIFRICE858
35000-998-71Colgate Optic White Stain Fighter Sens Relief1 in 1 CARTONPASTE, DENTIFRICE18
35000-998-71Colgate Optic White Stain Fighter Sens Relief119 g in 1 TUBEPASTE, DENTIFRICE1198

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-998COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]8Current NDC, 4 package rows20240608_6ec2fff7-df44-4302-be2d-97946c6cd66a.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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN6ec2fff7-df44-4302-be2d-97946c6cd66a8
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD6ec2fff7-df44-4302-be2d-97946c6cd66a8
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY6ec2fff7-df44-4302-be2d-97946c6cd66a8
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY6ec2fff7-df44-4302-be2d-97946c6cd66a8
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY6ec2fff7-df44-4302-be2d-97946c6cd66a8
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY6ec2fff7-df44-4302-be2d-97946c6cd66a8
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY6ec2fff7-df44-4302-be2d-97946c6cd66a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-998-60350000998601 TUBE in 1 CARTON (35000-998-60) / 85 g in 1 TUBE1 tube2022-11-012027-10-01NoNoHistorical
35000-998-71350000998711 TUBE in 1 CARTON (35000-998-71) / 119 g in 1 TUBE1 tube2022-11-012027-11-01NoNoHistorical