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 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.fc86b98e-d556-4769-e053-6394a90afc6e2026-01-08WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales1b6618ea-6533-41d7-be2c-13bb9e108dc52026-01-08WarningsExact identifier
application number: M022
equate SensitivePOTASSIUM NITRATE, SODIUM FLUORIDEWal-Mart Stores Inc79899b59-3a16-6504-e053-2991aa0a895a2026-01-08WarningsExact identifier
application number: M022
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.451283d3-78b0-8361-e063-6294a90a1fd52026-01-08WarningsExact identifier
application number: M022
CVS Maximum StrengthBENZOCAINECVS Pharmacy8691d6b6-741e-47b2-8332-76742b34715f2026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
application number: M022
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
application number: M022
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
application number: M022
Sootheez Organic Wild CherryPECTINBFY LLC47baa2a8-270c-fa07-e063-6394a90a97f62026-01-06WarningsExact identifier
application number: M022
Parodontax Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact identifier
application number: M022
MySweetSmile Toothpaste.MYSWEETSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478baf87-9276-7288-e063-6294a90a9e8e2026-01-04WarningsExact identifier
application number: M022
MySweetSmile Mango Toothpaste.MYSWEETSMILE MANGO TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cbdeb-28e1-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M022
Smile PaintSODIUM FLUORIDEJABBER JAW KIDS TOOTHPASTE LLCa7463b5c-53b2-4353-a5ea-800fbd7bd17d2026-01-02WarningsExact identifier
application number: M022
Dentek Canker CoverMENTHOLBershtel Enterprises2669183c-7a58-037e-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M022
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
application number: M022
AutoBrush WatermelonSODIUM FLUORIDELander Enterprises, LLC37a4e712-e3b5-42f6-971c-98dea4b8dd062025-12-31WarningsExact identifier
application number: M022
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC6bcd35f5-18ea-4fc8-84cd-06db73f38a1e2025-12-31WarningsExact identifier
application number: M022
AutoBrush BubblegumSODIUM FLUORIDELander Enterprises, LLCe7bf7e31-650d-4a1c-9100-48722344b2012025-12-31WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
application number: M022
Sensitive Mint Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.1e5e8b24-8304-482c-ae80-73effcc345da2025-12-23WarningsExact 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