FDA.reportPublic FDA data

Colgate Total SF Whitening

Product NDC
35000-176
11-digit product format
350000176
Labeler code
35000
Product ID
35000-176_5938ca36-bbe8-455b-8de8-892ec19f6162
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
2018-11-01
Marketing end
2026-12-31
Substance
STANNOUS FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-17635000-176-48DDiscontinued by firm2026-10-15
excluded packagepackage35000-17635000-176-78DDiscontinued by firm2026-10-15
excluded packagepackage35000-17635000-176-95DDiscontinued by firm2026-10-15
excluded packagepackage35000-17635000-176-96DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0535000-176-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-176-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-176-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-176-48d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-176-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-176-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-176-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-176-48f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-176-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-176-782ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-176-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-176-482ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-176-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-176-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-176-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-176-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-176-95cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-176-78cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-176-96cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-176-48cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-176-95cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-176-78cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-176-96cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-176-48cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-176-95302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-176-78302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-176-96302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-176-48302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-176-95ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-176-78ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-176-96ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-176-48ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-176-950efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-176-780efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-176-960efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-176-480efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0835000-176-95ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0835000-176-78ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0335000-176-95367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0335000-176-78367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0935000-176-78557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0935000-176-95557ba5c1ecfa…9c80585c8c6e…

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

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
86c4b51e-b086-4566-8f94-a951bf0c6254Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-176-14Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-14Colgate Total SF Whitening39 g in 1 TUBEPASTE, DENTIFRICE3916
35000-176-21Colgate Total SF Whitening59 g in 1 TUBEPASTE, DENTIFRICE5916
35000-176-21Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-25Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-25Colgate Total SF Whitening24.9 g in 1 TUBEPASTE, DENTIFRICE24.916
35000-176-32Colgate Total SF Whitening93 g in 1 TUBEPASTE, DENTIFRICE9316
35000-176-32Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-33Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-33Colgate Total SF Whitening36.8 g in 1 TUBEPASTE, DENTIFRICE36.816
35000-176-48Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-48Colgate Total SF Whitening136 g in 1 TUBEPASTE, DENTIFRICE13616
35000-176-60Colgate Total SF Whitening170 g in 1 TUBEPASTE, DENTIFRICE17016
35000-176-60Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-65Colgate Total SF Whitening144 g in 1 TUBEPASTE, DENTIFRICE14416
35000-176-65Colgate Total SF Whitening2 in 1 CARTONPASTE, DENTIFRICE216
35000-176-66Colgate Total SF Whitening144 g in 1 TUBEPASTE, DENTIFRICE14416
35000-176-66Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-78Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-78Colgate Total SF Whitening221 g in 1 TUBEPASTE, DENTIFRICE22116
35000-176-95Colgate Total SF Whitening178 g in 1 TUBEPASTE, DENTIFRICE17816
35000-176-95Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE116
35000-176-96Colgate Total SF Whitening136 g in 1 TUBEPASTE, DENTIFRICE13616
35000-176-96Colgate Total SF Whitening2 in 1 CARTONPASTE, DENTIFRICE216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-176COLGATE TOTAL SF WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]16Current NDC, Legacy NDC, 24 package rows20241003_86c4b51e-b086-4566-8f94-a951bf0c6254.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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SprinJene White BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp8c401bea-0148-46a0-bbb3-80c17f9e8e3e2026-08-14WarningsExact identifier
application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-13WarningsExact identifier
application number: M021
COLGATE STRAWBERRY BURSTSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-13WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRYSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.e36ceb7a-9a29-41d8-8d08-a859e515f1f52026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.08d7ed04-67a4-437a-82c5-496f9893c6c72026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.27278b02-c4fd-4092-a632-a14e442f5a952026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICESODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.59a6b9ac-c28b-4ec3-8231-f35054ce0eaf2026-08-10WarningsExact identifier
application number: M021
Toms Kids Watermelon WiggleSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.48eaafb6-99f4-5fd1-10fc-4ea35cbb2c622026-08-10WarningsExact identifier
application number: M021
AutoBrush kids bubblegumSODIUM FLUORIDELander Enterprises, LLC64b60e74-fceb-4de9-a966-73bf8dbd666c2026-08-10WarningsExact identifier
application number: M021
AutoBrush kids strawberrySODIUM FLUORIDELander Enterprises, LLC7e880d50-8aab-4d57-abc1-e900070f9a112026-08-10WarningsExact identifier
application number: M021
AutoBrush kids watermelonSODIUM FLUORIDELander Enterprises, LLC5cb5eb46-705c-4bb7-bef1-e93a598636fd2026-08-10WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC0e043431-9d87-478d-87f5-5aa8b0a932eb2026-08-10WarningsExact identifier
application number: M021
Willo Minty Mist Dye FreeSODIUM FLUORIDEWillo 32, Inc.3ee5b49e-ca9a-ece6-e063-6394a90a3d002026-08-10WarningsExact identifier
application number: M021
Willo Bubble TwistSODIUM FLUORIDEWillo 32 Inc36560d62-e901-1f93-e063-6394a90a28032026-08-10WarningsExact identifier
application number: M021
Willo Berry Splash Dye FreeSODIUM FLUORIDEWillo 32, Inc3ea91af9-2895-e530-e063-6394a90a39e52026-08-10WarningsExact identifier
application number: M021
Fluoride Mouth Rinse AnticavitySODIUM FLUORIDETarget Corporation3daf3cc3-585a-4bb2-9b56-7117d220ed382026-08-10Warnings, Adverse reactionsExact identifier
application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGOSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.19de1e71-ab94-415f-b66d-e5748dea83172026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.d5e1396e-0253-4ec0-a9ff-b61bda70de352026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED COOL MILD MINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.de92408c-d401-47c3-94ee-fb6c080926512026-08-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN86c4b51e-b086-4566-8f94-a951bf0c625416
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD86c4b51e-b086-4566-8f94-a951bf0c625416
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY86c4b51e-b086-4566-8f94-a951bf0c625416
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY86c4b51e-b086-4566-8f94-a951bf0c625416
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY86c4b51e-b086-4566-8f94-a951bf0c625416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-176-14350000176141 TUBE in 1 CARTON (35000-176-14) / 39 g in 1 TUBE1 tube2018-11-012026-12-31NoNoCurrent
35000-176-21350000176211 TUBE in 1 CARTON (35000-176-21) / 59 g in 1 TUBE1 tube2022-11-172026-12-31NoNoCurrent
35000-176-25350000176251 TUBE in 1 CARTON (35000-176-25) / 24.9 g in 1 TUBE1 tube2021-01-152026-12-31NoNoCurrent
35000-176-32350000176321 TUBE in 1 CARTON (35000-176-32) / 93 g in 1 TUBE1 tube2018-11-012026-12-31NoNoCurrent
35000-176-33350000176331 TUBE in 1 CARTON (35000-176-33) / 36.8 g in 1 TUBE1 tube2021-09-112026-12-31NoNoCurrent
35000-176-48350000176481 TUBE in 1 CARTON (35000-176-48) > 136 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
35000-176-60350000176601 TUBE in 1 CARTON (35000-176-60) / 170 g in 1 TUBE1 tube2021-02-122026-12-31NoNoCurrent
35000-176-65350000176652 TUBE in 1 CARTON (35000-176-65) / 144 g in 1 TUBE2 tube2021-12-012026-12-31NoNoCurrent
35000-176-66350000176661 TUBE in 1 CARTON (35000-176-66) / 144 g in 1 TUBE1 tube2021-12-272026-12-31NoNoCurrent
35000-176-78350000176781 TUBE in 1 CARTON (35000-176-78) > 221 g in 1 TUBE1 tube2018-11-012022-12-31NoNoCurrent
35000-176-95350000176951 TUBE in 1 CARTON (35000-176-95) > 178 g in 1 TUBE1 tube2018-11-012022-12-31NoNoCurrent
35000-176-96350000176962 TUBE in 1 CARTON (35000-176-96) > 136 g in 1 TUBE2 tube2018-11-010000-00-00NoNoCurrent