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 firm2026-10-15
excluded packagepackage35000-93635000-936-33DDiscontinued 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 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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
application number: M021
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
application number: M021
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEMKJ BRANDS LLC526acbdd-6531-692d-e063-6394a90ab9f12026-07-14WarningsExact 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