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 15 of 66 · 1,318 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PCXX MARSHMALLOW APF GSODIUM FLUORIDERoss Healthcare Inc.827459cc-faf2-3e7c-e053-2a91aa0aa4802026-03-02Exact identifier
unii: 8ZYQ1474W7
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: K679OBS311
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity RinseSODIUM FLUORIDEWalmart Inc.3beb65e4-ae8e-4e51-b9ba-181cbec41eff2026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEWalmart Inc.61669087-0af6-4192-b514-afcfe7d8ba982026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEWalmart Inc.e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d2026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Alcohol-Free AnticavitySODIUM FLUORIDEWalmart Inc.1fd2f3ca-066e-282a-e063-6294a90a05a92026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEWalmart Inc.af5b93e7-5cce-4e01-8df2-54494d8b29102026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEWalmart Inc.4590ca97-130c-46b2-9ba0-38f4703ef30a2026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
unii: K679OBS311
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
unii: K679OBS311
Anticavity RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32a92add-c9db-4733-8e35-613825fdf0812026-02-24Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32ebc633-5338-4d5a-b075-f10b247612482026-02-24Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity RinseSODIUM FLUORIDEH E B51ddc81b-1c90-4998-b538-6761ac1134372026-02-24Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEMeijer, Inc.9a0b6301-2443-41f7-adeb-87578a65c26d2026-02-24Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.344c9d00-ad82-46a9-83e9-68197e1a68bb2026-02-23Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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