FDA.reportPublic FDA data

Colgate MaxFresh with Whitening KnockOut Fluoride

Product NDC
35000-972
11-digit product format
350000972
Labeler code
35000
Product ID
35000-972_80878d16-ec55-43da-bd7a-37f3b2c7529e
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-05
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-97235000-972-60DDiscontinued by firm2026-10-12

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 MaxFresh with Whitening KnockOut Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92079d13-3b66-42b7-9990-2727a489b6f6Available on FDA.report

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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-972-58350000972581 TUBE in 1 CARTON (35000-972-58) / 70 g in 1 TUBE1 tube2016-01-050000-00-00NoNoCurrent
35000-972-60350000972601 TUBE in 1 CARTON (35000-972-60) > 170 g in 1 TUBE1 tube2016-01-050000-00-00NoNoCurrent
35000-972-63350000972631 TUBE in 1 CARTON (35000-972-63) / 178 g in 1 TUBE1 tube2022-04-050000-00-00NoNoCurrent
35000-972-99350000972991 TUBE in 1 CARTON (35000-972-99) / 54 g in 1 TUBE1 tube2024-04-03NoNoCurrent