FDA.reportPublic FDA data

Colgate Total SF Whitening

Product NDC
35000-275
11-digit product format
350000275
Labeler code
35000
Product ID
35000-275_70230766-3da5-4078-8641-459d4d37e213
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-18
Substance
STANNOUS FLUORIDE
Active strength
1.1 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 Total SF Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bba340e-2a62-3b04-41b5-0ed9c13adb13Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-275-32Colgate Total SF Whitening93 g in 1 TUBEGEL, DENTIFRICE932
35000-275-32Colgate Total SF Whitening1 in 1 CARTONGEL, DENTIFRICE12
35000-275-47Colgate Total SF Whitening1 in 1 CARTONGEL, DENTIFRICE12
35000-275-47Colgate Total SF Whitening144 g in 1 TUBEGEL, DENTIFRICE1442
35000-275-60Colgate Total SF Whitening1 in 1 CARTONGEL, DENTIFRICE12
35000-275-60Colgate Total SF Whitening170 g in 1 TUBEGEL, DENTIFRICE1702
35000-275-65Colgate Total SF Whitening2 in 1 CARTONGEL, DENTIFRICE22
35000-275-65Colgate Total SF Whitening144 g in 1 TUBEGEL, DENTIFRICE1442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-275COLGATE TOTAL SF WHITENING (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 8 package rows20241019_3bba340e-2a62-3b04-41b5-0ed9c13adb13.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 26 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
application number: M021
Crest Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
application number: M021
Burts Bees Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyc8350ab3-9347-58c0-e053-2995a90a72382026-01-08Exact identifier
application number: M021
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyddcb0871-9900-125f-e053-2a95a90a75de2026-01-08Exact identifier
application number: M021
Burts Bees Deep Clean plus WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc924b8dd-8d84-1329-e053-2995a90a45312026-01-08WarningsExact identifier
application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company07ed767e-225c-e9c5-e063-6394a90af9312026-01-08WarningsExact identifier
application number: M021
Crest Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Company087b3434-2636-74ce-e063-6394a90a25ad2026-01-08WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08776dfc-b07a-3729-e063-6394a90aeeed2026-01-08WarningsExact identifier
application number: M021
Crest Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company17f3b749-01ea-2561-e063-6294a90a5d3b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep CleanSODIUM FLUORIDEProcter & Gamble Manfuacturing Company128613c4-c06b-bdf5-e063-6294a90acd342026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company13a01190-a6f3-17b3-e063-6294a90a36c22026-01-08WarningsExact identifier
application number: M021
HEB HEBuddyFLUORIDEHEB2c972c65-34aa-4348-b997-c5e65a8845752026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN3bba340e-2a62-3b04-41b5-0ed9c13adb132
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD3bba340e-2a62-3b04-41b5-0ed9c13adb132
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY3bba340e-2a62-3b04-41b5-0ed9c13adb132
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY3bba340e-2a62-3b04-41b5-0ed9c13adb132
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY3bba340e-2a62-3b04-41b5-0ed9c13adb132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-275-32350000275321 TUBE in 1 CARTON (35000-275-32) / 93 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-275-47350000275471 TUBE in 1 CARTON (35000-275-47) / 144 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-275-60350000275601 TUBE in 1 CARTON (35000-275-60) / 170 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-275-65350000275652 TUBE in 1 CARTON (35000-275-65) / 144 g in 1 TUBE2 tube2024-10-18NoNoCurrent