FDA.reportPublic FDA data

NDC 65954-014-01 - Colgate Max Fresh Cool Mint

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65954-014
Requested NDC
65954-014-01
Package NDCs from labels
65954-014-60, 65954-014-01, 65954-014-75, 65954-014-78, 65954-014-99, 65954-014-58, 65954-014-63, 65954-014-95
Manufacturer
Mission Hills S.A de C.V | Colgate-Palmolive Company
Effective date
2019-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SODIUM FLUORIDE - Mission Hills S.A de C.V | Colgate-Palmolive CompanyMission Hills S.A de C.V | Colgate-Palmolive Company2019-04-09HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65954-014-792020-01-31C16284748780-19d75b9d0-4a92-f424-e053-dadaa90a57ce991f3000-a9e8-48a8-8165-046d143457a0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-014-01ColgateMax Fresh Cool Mint28.3 g in 1 TUBEGEL, DENTIFRICE28.316
65954-014-01ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-58ColgateMax Fresh Cool Mint70 g in 1 TUBEGEL, DENTIFRICE7016
65954-014-58ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-60ColgateMax Fresh Cool Mint170 g in 1 TUBEGEL, DENTIFRICE17016
65954-014-60ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-63ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-63ColgateMax Fresh Cool Mint178 g in 1 TUBEGEL, DENTIFRICE17816
65954-014-75ColgateMax Fresh Cool Mint79 g in 1 TUBEGEL, DENTIFRICE7916
65954-014-75ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-78ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-78ColgateMax Fresh Cool Mint221 g in 1 TUBEGEL, DENTIFRICE22116
65954-014-95ColgateMax Fresh Cool Mint178 g in 1 TUBEGEL, DENTIFRICE17816
65954-014-95ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-99ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE116
65954-014-99ColgateMax Fresh Cool Mint53 g in 1 TUBEGEL, DENTIFRICE5316

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-014COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]16Legacy NDC, 16 package rows20241127_d142e43f-415a-41c5-a7db-8b18a039a323.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6

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 51 of 65 · 1,293 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening ToothpasteSODIUM FLUORIDELG H&H Co.,Ltd.1a01481f-3e02-634e-e063-6394a90ac5fc2024-05-31WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyes Alive LubricatingCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDRIVIERA PHARMA INCb6966691-6884-438c-9f89-5924089226e12024-05-31WarningsExact identifier
unii: K679OBS311
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepackefb09948-ea45-4fea-a3c5-b981822710662024-05-29Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
unii: 8ZYQ1474W7
Dentalclean Doctor Duck Kids Flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda18806738-82fa-1a37-e063-6294a90a38882024-05-15WarningsExact identifier
unii: 8ZYQ1474W7
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
unii: 8ZYQ1474W7
Dentalclean Dr. Duck Strawberry flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1882c82a-3a32-5656-e063-6394a90ae0ed2024-05-15WarningsExact identifier
unii: 8ZYQ1474W7
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
unii: 8ZYQ1474W7
Dentalclean Booster KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186ecaeb-9401-9315-e063-6394a90a8e202024-05-14WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
unii: 8ZYQ1474W7
Dentalclean Doctor DuckSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186f2f12-279f-32df-e063-6394a90ad53d2024-05-14WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
unii: 8ZYQ1474W7
Dentalclean Regenerator Sensitive KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f31b5e-dd3b-78df-e063-6294a90a43ab2024-05-08WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
Dentalclean Dental Gel Booster Adult UseSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f3981f-ab4b-0dcd-e063-6294a90a37d92024-05-08WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
Dentalclean Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
Dentalclean Whitening MaxSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e2364e-2511-3021-e063-6294a90a40e12024-05-07WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
unii: 8ZYQ1474W7
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.