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 28 of 66 · 1,318 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Tap Water Detox 6018TAP WATER DETOXProfessional Complementary Health Formulasae0bca6a-118e-40a2-9108-14fc415524442026-01-08WarningsExact identifier
unii: 8ZYQ1474W7
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
unii: K679OBS311
FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLC0df8f1aa-f3ef-9f59-e063-6294a90a06662026-01-05Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
MySweetSmile Toothpaste.MYSWEETSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478baf87-9276-7288-e063-6294a90a9e8e2026-01-04WarningsExact identifier
unii: 8ZYQ1474W7
MySweetSmile Mango Toothpaste.MYSWEETSMILE MANGO TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cbdeb-28e1-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
unii: 8ZYQ1474W7
Smile PaintSODIUM FLUORIDEJABBER JAW KIDS TOOTHPASTE LLCa7463b5c-53b2-4353-a5ea-800fbd7bd17d2026-01-02WarningsExact identifier
rxcui: 416783
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
unii: 8ZYQ1474W7
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
AutoBrush WatermelonSODIUM FLUORIDELander Enterprises, LLC37a4e712-e3b5-42f6-971c-98dea4b8dd062025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC6bcd35f5-18ea-4fc8-84cd-06db73f38a1e2025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
AutoBrush BubblegumSODIUM FLUORIDELander Enterprises, LLCe7bf7e31-650d-4a1c-9100-48722344b2012025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
unii: 8ZYQ1474W7
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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