Colgate Total SF Whitening Gel

Product NDC
35000-175
11-digit product format
350000175
Labeler code
35000
Product ID
35000-175_63eccf8c-eaf0-431c-9b77-14475d78403b
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 packagepackage35000-17535000-175-48DDiscontinued by firm2026-10-16
excluded packagepackage35000-17535000-175-78DDiscontinued by firm2026-10-16
excluded packagepackage35000-17535000-175-95DDiscontinued by firm2026-10-16
excluded packagepackage35000-17535000-175-96DDiscontinued by firm2026-10-16

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 · 36 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 2025-12-0535000-175-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-175-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-175-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-175-96d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-175-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-175-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-175-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-175-96f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-175-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-175-782ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-175-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-175-962ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-175-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-175-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-175-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-175-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-175-95cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-175-78cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-175-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-175-96cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-175-95cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-175-78cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-175-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-175-96cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-175-95302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-175-78302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-175-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-175-96302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-175-95ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-175-78ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-175-48ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-175-96ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-175-950efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-175-780efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-175-480efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-175-960efc9e666f02…f202fb6c5f17…

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 Gel

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
27c4eed5-9121-4e09-9d42-e0a3e8430109Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-175-32Colgate Total SF Whitening Gel93 g in 1 TUBEPASTE, DENTIFRICE9312
35000-175-32Colgate Total SF Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE112
35000-175-48Colgate Total SF Whitening Gel136 g in 1 TUBEPASTE, DENTIFRICE13612
35000-175-48Colgate Total SF Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE112
35000-175-60Colgate Total SF Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE112
35000-175-60Colgate Total SF Whitening Gel170 g in 1 TUBEPASTE, DENTIFRICE17012
35000-175-65Colgate Total SF Whitening Gel2 in 1 CARTONPASTE, DENTIFRICE212
35000-175-65Colgate Total SF Whitening Gel144 g in 1 TUBEPASTE, DENTIFRICE14412
35000-175-66Colgate Total SF Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE112
35000-175-66Colgate Total SF Whitening Gel144 g in 1 TUBEPASTE, DENTIFRICE14412
35000-175-78Colgate Total SF Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE112
35000-175-78Colgate Total SF Whitening Gel221 g in 1 TUBEPASTE, DENTIFRICE22112
35000-175-95Colgate Total SF Whitening Gel178 g in 1 TUBEPASTE, DENTIFRICE17812
35000-175-95Colgate Total SF Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE112
35000-175-96Colgate Total SF Whitening Gel136 g in 1 TUBEPASTE, DENTIFRICE13612
35000-175-96Colgate Total SF Whitening Gel2 in 1 CARTONPASTE, DENTIFRICE212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-175COLGATE TOTAL SF WHITENING GEL (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]12Current NDC, Legacy NDC, 16 package rows20241003_27c4eed5-9121-4e09-9d42-e0a3e8430109.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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN27c4eed5-9121-4e09-9d42-e0a3e843010912
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD27c4eed5-9121-4e09-9d42-e0a3e843010912
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY27c4eed5-9121-4e09-9d42-e0a3e843010912
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY27c4eed5-9121-4e09-9d42-e0a3e843010912
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY27c4eed5-9121-4e09-9d42-e0a3e843010912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-175-32350000175321 TUBE in 1 CARTON (35000-175-32) / 93 g in 1 TUBE1 tube2018-11-012026-12-31NoNoCurrent
35000-175-48350000175481 TUBE in 1 CARTON (35000-175-48) > 136 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
35000-175-60350000175601 TUBE in 1 CARTON (35000-175-60) / 170 g in 1 TUBE1 tube2021-02-102026-12-31NoNoCurrent
35000-175-65350000175652 TUBE in 1 CARTON (35000-175-65) / 144 g in 1 TUBE2 tube2021-12-012026-12-31NoNoCurrent
35000-175-66350000175661 TUBE in 1 CARTON (35000-175-66) / 144 g in 1 TUBE1 tube2021-12-272026-12-31NoNoCurrent
35000-175-78350000175781 TUBE in 1 CARTON (35000-175-78) > 221 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
35000-175-95350000175951 TUBE in 1 CARTON (35000-175-95) > 178 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
35000-175-96350000175962 TUBE in 1 CARTON (35000-175-96) > 136 g in 1 TUBE2 tube2018-11-010000-00-00NoNoCurrent