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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact 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