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 38 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
application number: M022
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDegasa, S.A. de C.V.45ac0275-4c68-3897-e054-00144ff8d46c2023-11-05WarningsExact 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