FDA.reportPublic FDA data

Colgate Total SF Whitening

Product NDC
35000-274
11-digit product format
350000274
Labeler code
35000
Product ID
35000-274_78273a66-b594-45cd-9bb6-ef1635ba153a
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, 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
7f6b6aa8-50da-151b-c448-9e427d37398fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-274-14Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-14Colgate Total SF Whitening39.6 g in 1 TUBEPASTE, DENTIFRICE39.61
35000-274-21Colgate Total SF Whitening59 g in 1 TUBEPASTE, DENTIFRICE591
35000-274-21Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-25Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-25Colgate Total SF Whitening24.9 g in 1 TUBEPASTE, DENTIFRICE24.91
35000-274-32Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-32Colgate Total SF Whitening93 g in 1 TUBEPASTE, DENTIFRICE931
35000-274-47Colgate Total SF Whitening144 g in 1 TUBEPASTE, DENTIFRICE1441
35000-274-47Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-60Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-60Colgate Total SF Whitening170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-274-65Colgate Total SF Whitening2 in 1 CARTONPASTE, DENTIFRICE21
35000-274-65Colgate Total SF Whitening144 g in 1 TUBEPASTE, DENTIFRICE1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-274COLGATE TOTAL SF WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 14 package rows20241019_7f6b6aa8-50da-151b-c448-9e427d37398f.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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY7f6b6aa8-50da-151b-c448-9e427d37398f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-274-14350000274141 TUBE in 1 CARTON (35000-274-14) / 39.6 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-21350000274211 TUBE in 1 CARTON (35000-274-21) / 59 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-25350000274251 TUBE in 1 CARTON (35000-274-25) / 24.9 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-32350000274321 TUBE in 1 CARTON (35000-274-32) / 93 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-47350000274471 TUBE in 1 CARTON (35000-274-47) / 144 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-60350000274601 TUBE in 1 CARTON (35000-274-60) / 170 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-65350000274652 TUBE in 1 CARTON (35000-274-65) / 144 g in 1 TUBE2 tube2024-10-18NoNoCurrent