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 firm2026-10-15
excluded packagepackage35000-93735000-937-30DDiscontinued by firm2026-10-15
excluded packagepackage35000-93735000-937-33DDiscontinued 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 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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact 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