COLGATE OPTIC WHITE SENSITIVITY RELIEF

Product NDC
35000-093
11-digit product format
350000093
Labeler code
35000
Product ID
35000-093_e00560d8-73c6-4939-9ba0-36dcad2a6def
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE, POTASSIUM NITRATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-18
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
1.1; 50 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
COLGATE OPTIC WHITE SENSITIVITY RELIEF
Brand name suffix
SOOTHING MINT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g
POTASSIUM NITRATE50 mg/g

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 25 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.0192ccf9-1715-4e23-a6bf-8bd838cd8b0d2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.edcb8451-6fa7-4bc2-95f6-2a0806f7f3da2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.576660ed-203a-4842-9d39-c5be10daf9762025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.1796b3ec-833a-4cf1-ba50-bc4da827f84f2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.d923fa75-f556-45e3-9f52-39a62e89984b2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.cd3ede8c-2c77-4d81-8dff-8198025a21562025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citya225d515-430d-4e34-846c-0bfec3e741092025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City372f99c9-4ad3-4631-b8c8-2a34c47343cc2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citye554b5b2-cf91-464a-a930-3e1087f12c8d2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City98da331c-76c2-49fe-b687-6bfba4ae2e752025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd2195efa-597d-4ba9-a9b0-8df0d8f493112025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityfba82d55-94db-4432-b532-603fe57202be2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City9ed0fe31-e5f2-4d6d-8686-1286c66598472025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd5f42c30-343c-4e1d-950c-89bbd361fd272025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City7dce407f-bbe4-4a27-97ff-be33fd4474612025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f28f3-a908-47a9-e053-2995a90a6cbd2025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.921bdb76-f6d3-4e0a-a0ac-277dcc4e8d282025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.a80cfd29-8314-4639-a811-afd5fdb630b02025-01-09WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-093-59350000093591 TUBE in 1 CARTON (35000-093-59) / 107 g in 1 TUBE1 tube2026-09-18NoNoCurrent