FDA.reportPublic FDA data

Colgate MaxFresh Clean Mint

Product NDC
35000-212
11-digit product format
350000212
Labeler code
35000
Product ID
35000-212_73a89589-9ecc-4b06-b85c-7ac0f92b58d9
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
2025-02-03
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-212-30Colgate MaxFresh Clean Mint3 in 1 CELLO PACKGEL, DENTIFRICE31
35000-212-30Colgate MaxFresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE11
35000-212-62Colgate MaxFresh Clean Mint2 in 1 CARTONGEL, DENTIFRICE21
35000-212-62Colgate MaxFresh Clean Mint170 g in 1 TUBEGEL, DENTIFRICE1701
35000-212-95Colgate MaxFresh Clean Mint178 g in 1 TUBEGEL, DENTIFRICE1781
35000-212-95Colgate MaxFresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-212COLGATE MAXFRESH CLEAN MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 6 package rows20250204_eabc263f-92fc-21a0-b571-c8328bc953d3.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 % ToothpastePSNeabc263f-92fc-21a0-b571-c8328bc953d31
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDeabc263f-92fc-21a0-b571-c8328bc953d31
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYeabc263f-92fc-21a0-b571-c8328bc953d31
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYeabc263f-92fc-21a0-b571-c8328bc953d31
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYeabc263f-92fc-21a0-b571-c8328bc953d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-212-30350000212303 CARTON in 1 CELLO PACK (35000-212-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2025-02-03NoNoCurrent
35000-212-62350000212622 TUBE in 1 CARTON (35000-212-62) / 178 g in 1 TUBE2 tube2025-02-03NoNoCurrent
35000-212-95350000212951 TUBE in 1 CARTON (35000-212-95) / 178 g in 1 TUBE1 tube2025-02-03NoNoCurrent