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 60 of 65 · 1,293 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Iris 60 Second APF	SODIUM FLUORIDE	Benco Dental	5fa57e34-5827-4d37-a5dc-965750e5be50	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Iris 60 Second APF	SODIUM FLUORIDE	Benco Dental	6a0f889d-5f27-496f-b830-d778ee867ade	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Iris 60 Second APF	SODIUM FLUORIDE	Benco Dental	8f5d420b-3348-4002-9a09-b05e8cbb35c9	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Iris 60 Second APF	SODIUM FLUORIDE	Benco Dental	c93f67f5-9833-4a7a-a67a-49a51843e68d	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Iris 60 Second APF	SODIUM FLUORIDE	Benco Dental	d5658bf8-3a13-4d8b-b727-5f1575919571	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart Neutral pH	SODIUM FLUORIDE	Burkhart Dental Supply Inc	a7259222-4ee1-42b2-8beb-3f29a5eb2909	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart Neutral pH	SODIUM FLUORIDE	Burkhart Dental Supply Inc	0fb4d584-36e8-4db7-b72e-04608580dacd	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	2531ad94-b229-4212-a7a3-f793567a06b6	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	804e7850-1952-4e86-804e-d800ee6e7b50	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	87b3b8b8-780f-492d-bd75-b005edd55baa	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	79fa0a42-bb69-49db-9997-1679a75bac26	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	d7422939-c28e-4bda-b679-81abcc8c36e2	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	192c4e46-0bfd-4f48-901c-ce4f09f91e3e	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	5ef9652f-4d99-493d-97ee-9807c6f39182	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	8d1997c0-4f61-46b5-954e-620d521d3fba	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	9cbfd85a-a930-4a4b-a362-b142f6312c59	2022-02-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	26b1f8ab-3540-4c3f-95ab-e9cb1c5cee97	2022-01-25	Warnings	Exact identifier unii: 8ZYQ1474W7
60 Second Fluoride Gel	SODIUM FLUORIDE	Darby Dental Supply, LLC	acb56376-a6da-45e0-9896-a890137d6c2d	2022-01-24	Warnings	Exact identifier unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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