FDA.reportPublic FDA data

Colgate Total SF Advanced Whitening

Product NDC
35000-178
11-digit product format
350000178
Labeler code
35000
Product ID
35000-178_54eebf5f-0d5a-40d0-9b4f-fface020bc3d
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
2019-05-14
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-17835000-178-14DDiscontinued by firm2026-10-15
excluded packagepackage35000-17835000-178-25DDiscontinued by firm2026-10-15
excluded packagepackage35000-17835000-178-47DDiscontinued by firm2026-10-15
excluded packagepackage35000-17835000-178-65DDiscontinued by firm2026-10-15
excluded packagepackage35000-17835000-178-93DDiscontinued 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 · 60 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 2025-12-0535000-178-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-178-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-178-47d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-178-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-178-65d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-178-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-178-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-178-47f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-178-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-178-65f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-178-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-178-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-178-472ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-178-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-178-652ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-178-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-178-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-178-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-178-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-178-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-178-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-178-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-178-47cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-178-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-178-65cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-178-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-178-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-178-47cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-178-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-178-65cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-178-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-178-93302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-178-47302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-178-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-178-65302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-178-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-178-93ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-178-47ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-178-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-178-65ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-178-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-178-930efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-178-470efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-178-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-178-650efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0835000-178-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0835000-178-93ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0835000-178-47ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0835000-178-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0835000-178-65ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0335000-178-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0335000-178-93367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0335000-178-47367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0335000-178-14367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0335000-178-65367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0935000-178-47557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0935000-178-65557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0935000-178-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0935000-178-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0935000-178-93557ba5c1ecfa…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 Advanced 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
f8aeac8e-6a3e-4ada-bb13-db337b934ba3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-178-14Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-14Colgate Total SF Advanced Whitening39.6 g in 1 TUBEPASTE, DENTIFRICE39.614
35000-178-18Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-18Colgate Total SF Advanced Whitening5 in 1 CELLO PACKPASTE, DENTIFRICE514
35000-178-25Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-25Colgate Total SF Advanced Whitening24.9 g in 1 TUBEPASTE, DENTIFRICE24.914
35000-178-47Colgate Total SF Advanced Whitening144 g in 1 TUBEPASTE, DENTIFRICE14414
35000-178-47Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-64Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-64Colgate Total SF Advanced Whitening181 g in 1 TUBEPASTE, DENTIFRICE18114
35000-178-65Colgate Total SF Advanced Whitening144 g in 1 TUBEPASTE, DENTIFRICE14414
35000-178-65Colgate Total SF Advanced Whitening2 in 1 CARTONPASTE, DENTIFRICE214
35000-178-93Colgate Total SF Advanced Whitening96 g in 1 TUBEPASTE, DENTIFRICE9614
35000-178-93Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-178COLGATE TOTAL SF ADVANCED WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]14Current NDC, Legacy NDC, 14 package rows20240929_f8aeac8e-6a3e-4ada-bb13-db337b934ba3.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 38 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35839b10-4c40-40e5-e063-6294a90a85b42025-05-19WarningsExact identifier
application number: M021
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride WatermelonSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb506df13-649f-4615-bc25-6ae08bd56b182025-05-12WarningsExact identifier
application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
application number: M021
Brush Buddies Value 2 pack WhiteningSODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc636bf51d-9750-4305-ab4a-3483c9f0169b2025-04-30WarningsExact identifier
application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf8aeac8e-6a3e-4ada-bb13-db337b934ba314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-178-14350000178141 TUBE in 1 CARTON (35000-178-14) > 39.6 g in 1 TUBE1 tube2019-05-142023-03-31NoNoCurrent
35000-178-18350000178185 CARTON in 1 CELLO PACK (35000-178-18) / 1 TUBE in 1 CARTON / 181 g in 1 TUBE5 carton2023-03-202026-12-31NoNoHistorical
35000-178-25350000178251 TUBE in 1 CARTON (35000-178-25) > 24.9 g in 1 TUBE1 tube2019-05-142022-12-31NoNoCurrent
35000-178-47350000178471 TUBE in 1 CARTON (35000-178-47) > 144 g in 1 TUBE1 tube2019-05-140000-00-00NoNoCurrent
35000-178-64350000178641 TUBE in 1 CARTON (35000-178-64) / 181 g in 1 TUBE1 tube2019-05-142026-12-31NoNoCurrent
35000-178-65350000178652 TUBE in 1 CARTON (35000-178-65) > 144 g in 1 TUBE2 tube2019-05-142023-01-31NoNoCurrent
35000-178-93350000178931 TUBE in 1 CARTON (35000-178-93) > 96 g in 1 TUBE1 tube2019-05-140000-00-00NoNoCurrent