FDA.reportPublic FDA data

Colgate MaxFresh Clean Mint

Product NDC
35000-212
11-digit product format
350000212
Labeler code
35000
Product ID
35000-212_554c26e7-6968-4d95-b154-ce0a6dd4ce0f
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate MaxFresh Clean Mint
Listing expiration
2026-12-31

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
eabc263f-92fc-21a0-b571-c8328bc953d3Available on FDA.report

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 1 of 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact 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) / 170 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