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 40 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
application number: M021
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
application number: M021
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact 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