FDA.reportPublic FDA data

Colgate MaxClean with Whitening Smartfoam

Product NDC
35000-028
11-digit product format
350000028
Labeler code
35000
Product ID
35000-028_841d36db-fb86-4fe9-9929-ccf2539d8292
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-24
Marketing end
2026-12-01
Substance
SODIUM 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-02835000-028-60DDiscontinued 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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…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 MaxClean with Whitening Smartfoam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c712ae6b-eff3-4c54-b1fc-37304758d059Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-028-60Colgate MaxClean with Whitening Smartfoam1 in 1 CARTONPASTE, DENTIFRICE110
35000-028-60Colgate MaxClean with Whitening Smartfoam170 g in 1 TUBEPASTE, DENTIFRICE17010
35000-028-63Colgate MaxClean with Whitening Smartfoam1 in 1 CARTONPASTE, DENTIFRICE110
35000-028-63Colgate MaxClean with Whitening Smartfoam178 g in 1 TUBEPASTE, DENTIFRICE17810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-028COLGATE MAXCLEAN WITH WHITENING SMARTFOAM (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]10Current NDC, Legacy NDC, 4 package rows20250503_c712ae6b-eff3-4c54-b1fc-37304758d059.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 15 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32ebc633-5338-4d5a-b075-f10b247612482026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEH E B51ddc81b-1c90-4998-b538-6761ac1134372026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.9a0b6301-2443-41f7-adeb-87578a65c26d2026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.344c9d00-ad82-46a9-83e9-68197e1a68bb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Complete Oral RinseANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.27c33ae1-52c7-baad-e063-6394a90a06112026-02-23WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.001777fb-196c-499a-94c8-6cdcef0958e92026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.c628d02f-c834-42b3-b38d-6b9cdcdd09612026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.b17f7a5d-272e-446d-803b-46a6d8e5f18f2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEMeijer, Inc.d85ce60c-ebff-461f-827a-10fddb9c2bf32026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
White Glo Charcoal Baking Soda Maximum White Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc580c4622-6f9c-48ea-b01e-6ffba7273f242026-02-19WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Incf044e213-2403-4f42-a41d-72d58fefcfcb2026-02-19WarningsExact identifier
application number: M021
White Glo Mouthwash Protect Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4691584f-8c0c-4589-8b40-89b1779a438d2026-02-19WarningsExact identifier
application number: M021
White Glo Professional Choice Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inced8d7506-0385-4422-be77-bcc2db79882f2026-02-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEMeijer, Inc.c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEMeijer, Inc.af34f83f-1328-4897-9d04-72ca5a4101bf2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.acff939e-e98c-4d89-a0c4-0254dc74e6722026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDEMeijer, Inc.0bb9fb5f-1893-4187-b60b-05319a8fac6a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Intense Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC4b0404af-309f-7c31-e063-6294a90a5aa12026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETarget Corporationabfc1973-60ab-44e5-8147-33739d8bd7a32026-02-18Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETarget Corporation3e4119b2-9506-4305-8cff-163f700265d02026-02-18Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNc712ae6b-eff3-4c54-b1fc-37304758d05910
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDc712ae6b-eff3-4c54-b1fc-37304758d05910
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYc712ae6b-eff3-4c54-b1fc-37304758d05910
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYc712ae6b-eff3-4c54-b1fc-37304758d05910
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYc712ae6b-eff3-4c54-b1fc-37304758d05910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-028-60350000028601 TUBE in 1 CARTON (35000-028-60) > 170 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent
35000-028-63350000028631 TUBE in 1 CARTON (35000-028-63) / 178 g in 1 TUBE1 tube2021-11-012026-12-01NoNoCurrent