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 44 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companycef9a30c-a18c-47e9-b276-f56608f0400f2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company86c4b51e-b086-4566-8f94-a951bf0c62542024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening Fresh BoostSTANNOUS FLUORIDEColgate-Palmolive Companyc436382e-2755-c882-2970-4be1b9ca537b2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Whitening GelSTANNOUS FLUORIDEColgate-Palmolive Company27c4eed5-9121-4e09-9d42-e0a3e84301092024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company56434e3d-ba0a-8b42-6c97-0d00556067932024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Mint Stripe GelSTANNOUS FLUORIDEColgate-Palmolive Companyabfbcacd-9c1a-4472-9e91-a85e78050a9e2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
application number: M021
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios Inc.b197ac2d-f9d6-4937-a0a6-2f425e4c37962024-09-26WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios, Incdc04ee5c-3561-4579-8f9b-00266a8c88712024-09-25WarningsExact identifier
application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)SODIUM FLUORIDEMADE BY DENTISTS INC94939abe-b05e-4ea2-a1a6-204da857b4aa2024-09-18WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
application number: M021
CinnaFreshSODIUM FLUORIDEBob Barker Company Inc.3fbd95f0-a10c-4351-ad80-7e90b2d6a6f52024-08-22WarningsExact identifier
application number: M021
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
application number: M021
Karl and Hans Botanic JasmineSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION6c0335e6-f041-48c7-9da3-88c124b84b002024-08-08WarningsExact identifier
application number: M021
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact 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