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 49 of 65 · 1,293 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rexall Sensitive Freshmint	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	7e715bb9-666e-4de4-ba70-1c84f5243443	2024-10-14	Warnings	Exact identifier unii: 8ZYQ1474W7
Rexall Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	2daf18a3-f71e-4585-8128-4663eff7eb6d	2024-10-14	Warnings	Exact identifier unii: 8ZYQ1474W7
Eye Wash	WATER SOLUTION	Kroger Company	354402ad-581d-47e7-9fd3-933bef281ff4	2024-10-11	Warnings	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	Hubei Changjian Medical Products Co., Ltd.	d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea	2024-10-11	Warnings	Exact identifier unii: 059QF0KO0R
Crest Cavity Protection Regular	SODIUM FLUORIDE	Navajo Manufacturing Company Inc.	23851360-e30e-dd97-e063-6394a90a5474	2024-10-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Household Detox	PTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLON	Deseret Biologicals, Inc.	7e32c1f4-c88e-43d0-9f6c-de736d358d46	2024-09-27	Warnings	Exact identifier unii: K679OBS311
Household Antigens	ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR	Energique, Inc.	87c92497-8a51-4977-87fe-e0b4c6bafb19	2024-09-27	Warnings	Exact identifier unii: 368GB5141J
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef	2024-09-27	Warnings	Exact identifier unii: 8ZYQ1474W7
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR	SODIUM FLUORIDE	Ashtel Studios Inc.	b197ac2d-f9d6-4937-a0a6-2f425e4c3796	2024-09-26	Warnings	Exact identifier unii: 8ZYQ1474W7
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc	dc04ee5c-3561-4579-8f9b-00266a8c8871	2024-09-25	Warnings	Exact identifier unii: 8ZYQ1474W7
Made by Dentists For Kids Cheetah Dust (Strawberry)	SODIUM FLUORIDE	MADE BY DENTISTS INC	94939abe-b05e-4ea2-a1a6-204da857b4aa	2024-09-18	Warnings	Exact identifier rxcui: 416783 unii: 8ZYQ1474W7
Sensodyne Pronamel Gentle Whitening Advanced	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	94e07979-943b-45bb-8e2b-90d686f3692e	2024-09-04	Warnings	Exact identifier unii: 8ZYQ1474W7
Sensodyne Pronamel Gentle Whitening Advanced Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	6eb304dd-2a24-4fa0-9d39-71264e88dd16	2024-08-29	Warnings	Exact identifier unii: 8ZYQ1474W7
ACT Anticavity Fluoride Arctic Blast	SODIUM FLUORIDE	Chattem, Inc.	2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57	2024-08-22	Warnings	Exact identifier unii: 8ZYQ1474W7
CinnaFresh	SODIUM FLUORIDE	Bob Barker Company Inc.	3fbd95f0-a10c-4351-ad80-7e90b2d6a6f5	2024-08-22	Warnings	Exact identifier unii: 8ZYQ1474W7
Sensodyne Pronamel Clinical Enamel Strength Deep Clean	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cfda7efa-86fa-470d-a79f-81907e31778a	2024-08-14	Warnings	Exact identifier unii: 8ZYQ1474W7
Sensodyne Pronamel Kids Bubble Twist	SODIUM FLUORIDE	Haleon US Holdings LLC	e403529a-0fac-4dab-b75c-46906add096b	2024-08-13	Warnings	Exact identifier unii: 8ZYQ1474W7
Empathy	AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA	Deseret Biologicals, Inc.	a89067c1-ef12-49da-8fa6-e65ff664f497	2024-08-13	Warnings	Exact identifier unii: 059QF0KO0R
Sodium Fluoride Chewable	SODIUM FLUORIDE	Bryant Ranch Prepack	4ce32ee3-cd20-4663-a169-fa78ebd20477	2024-08-05	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Clinpro Tooth Creme	SODIUM FLUORIDE	Solventum US LLC	786c6184-6bc8-4376-9ce2-3e35af193210	2024-08-01	Warnings	Exact identifier unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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