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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact 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