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
Label	Manufacturer	Effective date	Type
SODIUM FLUORIDE - Mission Hills S.A de C.V \| Colgate-Palmolive Company	Mission Hills S.A de C.V \| Colgate-Palmolive Company	2019-04-09	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65954-014-79	2020-01-31	C162847	48780-1	9d75b9d0-4a92-f424-e053-dadaa90a57ce	991f3000-a9e8-48a8-8165-046d143457a0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65954-014-01	ColgateMax Fresh Cool Mint	28.3 g in 1 TUBE	GEL, DENTIFRICE	28.3	16
65954-014-01	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-58	ColgateMax Fresh Cool Mint	70 g in 1 TUBE	GEL, DENTIFRICE	70	16
65954-014-58	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-60	ColgateMax Fresh Cool Mint	170 g in 1 TUBE	GEL, DENTIFRICE	170	16
65954-014-60	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-63	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-63	ColgateMax Fresh Cool Mint	178 g in 1 TUBE	GEL, DENTIFRICE	178	16
65954-014-75	ColgateMax Fresh Cool Mint	79 g in 1 TUBE	GEL, DENTIFRICE	79	16
65954-014-75	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-78	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-78	ColgateMax Fresh Cool Mint	221 g in 1 TUBE	GEL, DENTIFRICE	221	16
65954-014-95	ColgateMax Fresh Cool Mint	178 g in 1 TUBE	GEL, DENTIFRICE	178	16
65954-014-95	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-99	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-99	ColgateMax Fresh Cool Mint	53 g in 1 TUBE	GEL, DENTIFRICE	53	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65954-014	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	16	Legacy NDC, 16 package rows	20241127_d142e43f-415a-41c5-a7db-8b18a039a323.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLGATE 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 63 of 65 · 1,293 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gelato APF	SODIUM FLUORIDE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	c33e0e2e-7c68-4908-8bd4-6a3669c8774b	2022-01-19	Warnings	Exact identifier unii: 8ZYQ1474W7
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT	SODIUM FLUORIDE	DMG AMERICA, LLC	b83c62be-8e9d-4fa2-aa10-d34c88bf2387	2021-10-01	Warnings	Exact identifier unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT	SODIUM FLUORIDE	DMG AMERICA, LLC	427f25e6-e50a-407a-a6f0-512123e381e4	2021-10-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Wentworth Alcohol Free	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	5ed816ef-20bc-49ac-9202-8fac1edac579	2021-03-23	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm Dry Mouth	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	cbc67f03-55c4-4781-ba37-87c737b60282	2021-03-02	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, Inc.	ab9b07ad-f6b2-4289-bec4-fec58270dc97	2021-02-20	Warnings	Exact identifier unii: 8ZYQ1474W7
Avant	SODIUM FLUORIDE	Dharma Research, Inc.	4749dce1-c0b9-4737-8a30-85cd58aba21b	2021-01-25	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Avant	SODIUM FLUORIDE	Dharma Research, Inc.	184bbe52-3909-45f6-b4d0-fe7849fabc1c	2021-01-25	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Fluoride 5000 ppm Enamel Protect	SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%	Sheffield Pharmaceuticals LLC	83dfdead-4f71-404e-90ae-dbd6849c7cf1	2021-01-04	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Ionite APF Neutral	SODIUM FLUORIDE	Dharma Research, inc.	ad7a660b-274c-417e-bdf3-1d5addf06ad1	2020-11-18	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	8ff1b377-0535-4548-a109-f9f1a43b85b7	2020-11-16	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	e6c31330-43e0-4d32-af54-ff852af39cab	2020-11-16	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4	2020-11-16	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	b8b7f9b8-ff11-4a76-ab36-7822c15e1892	2020-11-16	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	e1797adf-4665-4322-a3aa-dd2da9dcd3a8	2020-11-16	Warnings	Exact identifier unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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