FDA.reportPublic FDA data

Colgate Optic White Stain Fighter Clean Mint

Product NDC
35000-937
11-digit product format
350000937
Labeler code
35000
Product ID
35000-937_5983a822-3f4b-4285-a824-b89d7a1cb746
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
2017-11-30
Marketing end
2027-10-27
Substance
SODIUM FLUORIDE
Active strength
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-93735000-937-02DDiscontinued by firm2026-10-12
excluded packagepackage35000-93735000-937-30DDiscontinued by firm2026-10-12
excluded packagepackage35000-93735000-937-33DDiscontinued by firm2026-10-12

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 Optic White Stain Fighter Clean Mint

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-937-02Colgate Optic White Stain Fighter Clean Mint1 in 1 CARTONPASTE, DENTIFRICE15
35000-937-02Colgate Optic White Stain Fighter Clean Mint56.6 g in 1 TUBEPASTE, DENTIFRICE56.65
35000-937-30Colgate Optic White Stain Fighter Clean Mint85 g in 1 TUBEPASTE, DENTIFRICE855
35000-937-30Colgate Optic White Stain Fighter Clean Mint1 in 1 CARTONPASTE, DENTIFRICE15
35000-937-33Colgate Optic White Stain Fighter Clean Mint1 in 1 CARTONPASTE, DENTIFRICE15
35000-937-33Colgate Optic White Stain Fighter Clean Mint36.8 g in 1 TUBEPASTE, DENTIFRICE36.85
35000-937-60Colgate Optic White Stain Fighter Clean Mint1 in 1 CARTONPASTE, DENTIFRICE15
35000-937-60Colgate Optic White Stain Fighter Clean Mint170 g in 1 TUBEPASTE, DENTIFRICE1705
35000-937-71Colgate Optic White Stain Fighter Clean Mint1 in 1 CARTONPASTE, DENTIFRICE15
35000-937-71Colgate Optic White Stain Fighter Clean Mint119 g in 1 TUBEPASTE, DENTIFRICE1195

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-937COLGATE OPTIC WHITE STAIN FIGHTER CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]5Current NDC, Legacy NDC, 10 package rows20241127_c78cb378-7f65-499c-b64b-d85b1e1bec22.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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.fdbadaae-eab7-4d9a-acf7-815ca93f877c2026-06-16WarningsExact identifier
application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.ebb62015-0027-459a-a9cf-56b640f9f4562026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.b9962eac-186e-4da2-929d-393f18ed02342026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.1c029b10-29b0-4131-9134-cebfca4328a32026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTARSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.3e7ab39a-989c-4924-af3e-689404912bee2026-06-16WarningsExact identifier
application number: M021
Crest Plus Cinnamon plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company53fb780d-3e8b-6747-e063-6294a90a82112026-06-11WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY7f6b6aa8-50da-151b-c448-9e427d37398f2026-06-11WarningsExact identifier
application number: M021
Colgate MaxClean with Whitening SmartfoamSODIUM FLUORIDEColgate-Palmolive Companyc712ae6b-eff3-4c54-b1fc-37304758d0592026-06-11WarningsExact identifier
application number: M021
Colgate Total Sensitivity Mineral ShieldSTANNOUS FLUORIDEColgate-Palmolive Companyf065318c-1e2a-c04d-f254-f8127b05a88f2026-06-10WarningsExact identifier
application number: M021
Toms Whole Care Mouthwash Fresh MintSODIUM FLUORIDETom's of Maine, Inc.6875f5c1-853c-43da-8226-c09a5518f9bb2026-06-10WarningsExact identifier
application number: M021
Colgate Total SF Fresh Mint StripeSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY657020c7-e85c-4c61-9f62-b50351e4b4e52026-06-10WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride BubblegumSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc1adc752b-2ba8-4d8f-b4f1-5741f864255b2026-06-09WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.df182c22-bbf1-448d-81e8-35cb431d2afc2026-06-08WarningsExact identifier
application number: M021
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride RaspberrySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc57e1d1cb-da58-4cd2-b960-4056e0b0d2142026-06-05WarningsExact identifier
application number: M021
3ECARE Dual FormulaWhiteningToothpasteSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.533fb7dd-7f84-59c5-e063-6394a90accad2026-06-02WarningsExact identifier
application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteethPOTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATEHangzhou Namei Zhikang Technology Co., Ltd.533fc83e-a8cf-15c1-e063-6294a90a7b742026-06-02WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNc78cb378-7f65-499c-b64b-d85b1e1bec225
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDc78cb378-7f65-499c-b64b-d85b1e1bec225
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYc78cb378-7f65-499c-b64b-d85b1e1bec225
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYc78cb378-7f65-499c-b64b-d85b1e1bec225
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYc78cb378-7f65-499c-b64b-d85b1e1bec225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-937-02350000937021 TUBE in 1 CARTON (35000-937-02) > 56.6 g in 1 TUBE1 tube2017-11-300000-00-00NoNoCurrent
35000-937-30350000937301 TUBE in 1 CARTON (35000-937-30) > 85 g in 1 TUBE1 tube2021-07-150000-00-00NoNoCurrent
35000-937-33350000937331 TUBE in 1 CARTON (35000-937-33) > 36.8 g in 1 TUBE1 tube2020-03-180000-00-00NoNoCurrent
35000-937-60350000937601 TUBE in 1 CARTON (35000-937-60) / 170 g in 1 TUBE1 tube2018-12-192027-10-27NoNoCurrent
35000-937-71350000937711 TUBE in 1 CARTON (35000-937-71) / 119 g in 1 TUBE1 tube2017-11-302027-10-02NoNoCurrent