Colgate MaxFresh Cool Mint

Product NDC
35000-211
11-digit product format
350000211
Labeler code
35000
Product ID
35000-211_85b700ad-7cad-4a72-86b5-482e15b895fb
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
2025-01-01
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 packagepackage35000-21135000-211-54DDiscontinued 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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35000-21135000-211-54DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Cool 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
35000-211-30Colgate MaxFresh Cool Mint3 in 1 CELLO PACKGEL, DENTIFRICE34
35000-211-30Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-54Colgate MaxFresh Cool Mint198 g in 1 TUBEGEL, DENTIFRICE1984
35000-211-54Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-55Colgate MaxFresh Cool Mint170 g in 1 TUBEGEL, DENTIFRICE1704
35000-211-55Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-73Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14
35000-211-73Colgate MaxFresh Cool Mint206 g in 1 TUBEGEL, DENTIFRICE2064
35000-211-95Colgate MaxFresh Cool Mint178 g in 1 TUBEGEL, DENTIFRICE1784
35000-211-95Colgate MaxFresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-211COLGATE MAXFRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE PALMOLIVE COMPANY]3Current NDC, 10 package rows20250119_e3dd6d27-6607-4b0c-83e1-49d94be2e580.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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frida Fluoride Sweet MintSODIUM FLUORIDEFridababy, LLC4f8b5a39-5d79-72cd-e063-6394a90a475c2026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Bubble MintSODIUM FLUORIDEFridababy, LLC4f8b9af3-e4b3-b5e0-e063-6394a90a10682026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Strawberry Toothbrush SetSODIUM FLUORIDEFridababy, LLC4f8ba14f-60ea-c2a8-e063-6394a90a77022026-05-06WarningsExact identifier
application number: M021
Frida Fluoride StrawberrySODIUM FLUORIDEFridababy, LLC4f814a62-8f91-8ea6-e063-6294a90a69eb2026-05-06WarningsExact identifier
application number: M021
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsExact identifier
application number: M021
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
application number: M021
Crest 3D White Stain EraserSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.fdefffbd-9c05-fa30-e053-6394a90a34bc2026-05-05WarningsExact identifier
application number: M021
Frida Fluoride WatermelonSODIUM FLUORIDEFridababy, LLC4f8b49dc-e9e4-c341-e063-6294a90adb5a2026-05-05WarningsExact identifier
application number: M021
White Glo Extreme White WhiteningSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4a2e0a8d-420e-4c07-aa43-386d05dab4722026-04-30WarningsExact identifier
application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TPSTANNOUS FLUORIDEWalmart Inc.1e6561fb-4e3b-40ba-e063-6294a90a26902026-04-29WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.852889b4-59ba-4592-b4fc-c0127a1ad0752026-04-28WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus ScopeSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.0206710a-707f-4aa9-96b9-86240c1275dc2026-04-28WarningsExact identifier
application number: M021
Alcohol Free Refreshing MintSODIUM FLUORIDEH E Bcedf7c08-7412-4733-9b67-225b331cec8c2026-04-27Warnings, Adverse reactionsExact identifier
application number: M021
anzoon ANTIBACTERIAL MOUTH WASHCETYLPYRIDINIUM CHLORIDEShandong AZC Biotechnology Co.,Ltd.507c6896-2806-790c-e063-6394a90ac5ce2026-04-27WarningsExact identifier
application number: M021
DELTA COMFORT PLUS AMENITYSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.26434794-ae02-0f58-e063-6294a90ad85e2026-04-24WarningsExact identifier
application number: M021
A and H Plus Therabreath Breath FreshnersSODIUM FLUORIDEChurch & Dwight Co., Inc.18d6073e-b1ee-47d2-9758-2cf04f3cf3ca2026-04-23WarningsExact identifier
application number: M021
FluorideSODIUM FLUORIDEMcKesson5025e58e-e59c-07b6-e063-6394a90ac1e82026-04-23WarningsExact identifier
application number: M021
PRO-SYSSENSITIVITY - MINT (OTC)Benco Dental4e46847e-8c1d-c988-e063-6394a90a8e502026-04-22WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E B87327a36-a314-4daa-83b6-b4bd3e26bba22026-04-22Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E B8df324a7-9204-40f3-8ddb-1656286d7d4e2026-04-22Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYe3dd6d27-6607-4b0c-83e1-49d94be2e5804
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYe3dd6d27-6607-4b0c-83e1-49d94be2e5804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-211-30350000211303 CARTON in 1 CELLO PACK (35000-211-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE3 carton2025-02-03NoNoCurrent
35000-211-5435000021154198 g in 1 TUBE198 gHistorical
35000-211-55350000211552 TUBE in 1 CARTON (35000-211-55) / 178 g in 1 TUBE2 tube2025-11-01NoNoCurrent
35000-211-73350000211731 TUBE in 1 CARTON (35000-211-73) / 206 g in 1 TUBE1 tube2025-02-03NoNoCurrent
35000-211-95350000211951 TUBE in 1 CARTON (35000-211-95) / 178 g in 1 TUBE1 tube2025-02-03NoNoCurrent