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 38 of 65 · 1,293 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TidaloveSPICY CINNAMON TOOTHPASTE TABLETSParanmare LLC4092fcbf-27f7-b067-e063-6394a90a41c62025-10-07WarningsExact identifier
unii: 8ZYQ1474W7
TidaloveCOOL MINT TOOTHPASTE TABLETSParanmare LLC4093060c-23a5-c77a-e063-6394a90a93042025-10-07WarningsExact identifier
unii: 8ZYQ1474W7
TidaloveYUZU MINT TOOTHPASTE TABLETSParanmare LLC40946943-21cf-b114-e063-6394a90aed3f2025-10-07WarningsExact identifier
unii: 8ZYQ1474W7
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
unii: 8ZYQ1474W7
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
unii: 8ZYQ1474W7
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INCb2ad2b19-6fdf-454d-9b1d-49b1c81016fd2025-09-30WarningsExact identifier
rxcui: 416783
unii: 8ZYQ1474W7
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.a38363e6-7105-4663-95a0-09ecb2948f832025-09-30WarningsExact identifier
unii: 8ZYQ1474W7
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Cloveden Sensitive Care ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD3fb153f1-ba6e-7251-e063-6294a90abe622025-09-26WarningsExact identifier
unii: 8ZYQ1474W7
Allday 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared92b84db-2202-33cc-e053-2a95a90a17532025-09-23WarningsExact identifier
unii: 8ZYQ1474W7
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
unii: 8ZYQ1474W7
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
unii: 8ZYQ1474W7
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
unii: 8ZYQ1474W7
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Cared9f232c0-d154-536b-e053-2995a90af37d2025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared9e462d9-f0fd-4168-e053-2995a90a95b22025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careac24342d-382e-6fc2-e053-2a95a90acd692025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careadf0c686-e6a1-03f5-e053-2a95a90ac7552025-09-19WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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