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 40 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
application number: M021
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
application number: M021
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact 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