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 firm2026-10-16
excluded packagepackage35000-93735000-937-30DDiscontinued by firm2026-10-16
excluded packagepackage35000-93735000-937-33DDiscontinued 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 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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5b18988-68c7-40f9-e053-2995a90a22bc2026-01-08WarningsExact identifier
application number: M021
CVS Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDECVS Pharmacy81b72da2-7f41-74ca-e053-2a91aa0a96462026-01-08WarningsExact identifier
application number: M021
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
application number: M021
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmartad3f645d-aaf9-2800-e053-2a95a90ab62f2026-01-08WarningsExact identifier
application number: M021
CVS Complete ProtectionSTANNOUS FLOURIDECVSb681b5e4-a0e1-8d0f-e053-2a95a90aa6722026-01-06WarningsExact identifier
application number: M021
Complete ProtectionSTANNOUS FLUORIDETarget03708e08-0189-b83d-e063-6394a90a50e62026-01-06WarningsExact identifier
application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
application number: M021
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
application number: M021
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
application number: M021
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
application number: M021
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
application number: M021
CloSYS Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.1a994f24-99ee-4b27-aab0-e816931a22c82025-12-23WarningsExact 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