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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Space Jam Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company54cbfb09-8fd7-ef08-99fd-14fc019c81ff2024-11-14WarningsExact identifier
application number: M021
Colgate Kids Llama Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolivea7b02cb2-cfb3-7b35-42da-7924d156dcc32024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Clean MintSODIUM FLUORIDEColgate-Palmolive Company82bc1101-84d7-4e21-be9c-870ad88a4b7c2024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDECOLGATE PALMOLIVE COMPANYb6ca4ec7-5087-4693-82b7-199b44d7f9312024-11-13WarningsExact identifier
application number: M021
Listerine Smart Rinse Berry SplashSODIUM FLUORIDEKenvue Brands LLC5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b2024-11-11WarningsExact identifier
application number: M021
Listerine Clinical Solutions Teeth Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC06e2de03-4a58-3de0-e063-6294a90a58572024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLCee9a962d-83c7-4b13-bff6-140e48785e8a2024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint ShieldSODIUM FLUORIDEKenvue Brands LLCd69d2e0d-a3e3-4d95-992d-c0c59172b3a52024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble BlastSODIUM FLUORIDEKenvue Brands LLCf09f334b-709c-473e-b91e-3f31480ceb902024-11-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDELG H&H Co.,Ltd.2697fa68-b991-ab09-e063-6394a90aec4c2024-11-01WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.2698d6d8-051b-6c10-e063-6394a90a94182024-11-01WarningsExact identifier
application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)SODIUM FLUORIDEMADE BY DENTISTS INC263c448b-728f-4370-bcdb-148d614d9b342024-10-30WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.17f589e9-f4ba-46d3-a345-db38f9a9067d2024-10-17WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Wild WatermelonSODIUM FLUORIDEChattem, Inc.8d7faeab-ac70-472a-acbb-de67493718ce2024-10-16WarningsExact identifier
application number: M021
Rexall Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEOld East Main CO.691c9638-75d2-4e53-bec4-2eafacd7216c2024-10-14WarningsExact identifier
application number: M021
Rexall Travel Toothbrush and Tooth-pasteSODIUM MONOFLUOROPHOSPHATEOld East Main CO.1bfba18b-1418-4c39-b666-96fa0674cc702024-10-14WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDENavajo Manufacturing Company Inc.23851360-e30e-dd97-e063-6394a90a54742024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact 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