FDA.reportPublic FDA data

Colgate Optic White Stain Fighter Fresh Mint

Product NDC
35000-936
11-digit product format
350000936
Labeler code
35000
Product ID
35000-936_6eff1247-a033-477c-a77e-737c386ce91d
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
2027-10-05
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-93635000-936-02DDiscontinued by firm2026-10-16
excluded packagepackage35000-93635000-936-33DDiscontinued 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 · 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 Fresh Mint

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-936-02Colgate Optic White Stain Fighter Fresh Mint56.6 g in 1 TUBEPASTE, DENTIFRICE56.66
35000-936-02Colgate Optic White Stain Fighter Fresh Mint1 in 1 CARTONPASTE, DENTIFRICE16
35000-936-33Colgate Optic White Stain Fighter Fresh Mint36.8 g in 1 TUBEPASTE, DENTIFRICE36.86
35000-936-33Colgate Optic White Stain Fighter Fresh Mint1 in 1 CARTONPASTE, DENTIFRICE16
35000-936-42Colgate Optic White Stain Fighter Fresh Mint119 g in 1 TUBEPASTE, DENTIFRICE1196
35000-936-42Colgate Optic White Stain Fighter Fresh Mint2 in 1 CARTONPASTE, DENTIFRICE26
35000-936-60Colgate Optic White Stain Fighter Fresh Mint170 g in 1 TUBEPASTE, DENTIFRICE1706
35000-936-60Colgate Optic White Stain Fighter Fresh Mint1 in 1 CARTONPASTE, DENTIFRICE16
35000-936-71Colgate Optic White Stain Fighter Fresh Mint119 g in 1 TUBEPASTE, DENTIFRICE1196
35000-936-71Colgate Optic White Stain Fighter Fresh Mint1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-936COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]6Current NDC, Legacy NDC, 10 package rows20250328_3dee7649-be7c-483c-a2b9-6939102ce5fb.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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsExact identifier
application number: M021
EverSmile SquirtSODIUM FLUORIDE 0.05%Everbrands, Inc.bc0ef174-2909-469a-b629-0eab4412bdfc2026-04-20WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf2026-04-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEH E B8d40f693-083c-4eb6-9da1-42675d757e0e2026-04-16Warnings, Adverse reactionsExact identifier
application number: M021
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.6753b426-6d49-4438-a52f-c28e60a0e9d82026-04-16WarningsExact identifier
application number: M021
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Enamel StrengthSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4f6b8851-c778-8abd-e063-6294a90aef4f2026-04-14Exact identifier
application number: M021
Crest 3D White Stain Eraser Luxe MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6beb3b-2521-bfb7-e063-6394a90ad9ea2026-04-14Exact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d132026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6d11b2-5aa2-ab34-e063-6294a90ac0bc2026-04-14WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEPublix Super Markets, Inc.cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb2026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.f0e84078-499f-4a5a-bcd2-23f57805de862026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
Crest Pro-Health Advanced Multi-ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1cfc5b61-c8e5-943d-e063-6394a90a890b2026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Multi-Protection plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6f6299-f95f-2f0e-e063-6294a90a16412026-04-14WarningsExact identifier
application number: M021
Crest 3D White Strength Whitening Enamel ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f7125aa-3aa2-ca64-e063-6394a90a4cf32026-04-14WarningsExact identifier
application number: M021
Eversmile TheraFoam0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.57da2479-923a-45ec-8149-57b469b116372026-04-13WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company4f1d62ae-653e-3046-e063-6294a90abbf82026-04-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN3dee7649-be7c-483c-a2b9-6939102ce5fb6
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3dee7649-be7c-483c-a2b9-6939102ce5fb6
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3dee7649-be7c-483c-a2b9-6939102ce5fb6
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3dee7649-be7c-483c-a2b9-6939102ce5fb6
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3dee7649-be7c-483c-a2b9-6939102ce5fb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-936-02350000936021 TUBE in 1 CARTON (35000-936-02) > 56.6 g in 1 TUBE1 tube2019-03-120000-00-00NoNoCurrent
35000-936-33350000936331 TUBE in 1 CARTON (35000-936-33) > 36.8 g in 1 TUBE1 tube2020-03-180000-00-00NoNoCurrent
35000-936-42350000936422 TUBE in 1 CARTON (35000-936-42) / 119 g in 1 TUBE2 tube2024-01-012027-10-03NoNoHistorical
35000-936-60350000936601 TUBE in 1 CARTON (35000-936-60) / 170 g in 1 TUBE1 tube2018-12-192027-10-04NoNoCurrent
35000-936-71350000936711 TUBE in 1 CARTON (35000-936-71) / 119 g in 1 TUBE1 tube2017-11-302027-10-05NoNoCurrent