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 64 of 65 · 1,293 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	ce34c159-34cd-47c7-937f-743b3309742b	2020-11-16	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF	SODIUM FLUORIDE	Dharma Research, inc.	503ca71a-f50c-4406-b925-5b6ac36a9212	2020-11-15	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite R	SODIUM FLUORIDE	Dharma Research, Inc.	1009afc7-6e9d-417f-a702-f8a941e08484	2020-11-06	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Ionite R	SODIUM FLUORIDE	Dharma Research, Inc.	0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5	2020-11-06	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Ionite APF Foam	SODIUM FLUORIDE	Dharma Research, inc.	d22afac7-45d6-467e-951a-e7c241b9180d	2020-10-27	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF Foam	SODIUM FLUORIDE	Dharma Research, inc.	4828b482-486f-4105-bed0-3fe2ddbbddb1	2020-10-27	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF Foam	SODIUM FLUORIDE	Dharma Research, Inc.	8987b447-3fa3-4f52-aecc-80e44c981aaa	2020-10-27	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF Neutral	SODIUM FLUORIDE	Dharma Research, inc.	8191554f-adb6-4ba9-aa80-0a9bb65193ec	2020-10-27	Warnings	Exact identifier unii: 8ZYQ1474W7
Ionite APF Foam	SODIUM FLUORIDE	Dharma Research, inc.	ddd34623-cb79-4fa7-bd01-19122470b63d	2020-10-27	Warnings	Exact identifier unii: 8ZYQ1474W7
FluoriMax 5000	1.1% SODIUM FLUORIDE TOOTHPASTE	Elevate Oral Care	ae45ae2d-a21f-0a05-e053-2995a90a4d5e	2020-09-01	Warnings	Exact identifier unii: 8ZYQ1474W7
FluoriMax 5000 Sensitive	1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE	Elevate Oral Care	ae32b0a2-e42f-6a56-e053-2a95a90a0b00	2020-08-31	Warnings	Exact identifier unii: 8ZYQ1474W7
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Sodium Fluoride 5000 ppm Sensitive	SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%	Sheffield Pharmaceuticals LLC	02f4cf0b-188c-4522-b759-ffe4a9d150e8	2020-04-01	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Sorbitol	SORBITOL	Baxter Healthcare Corporation	aea0b5a1-444b-4330-a3ce-26485dbbfe75	2019-12-31	Warnings, Adverse reactions	Exact identifier unii: 506T60A25R
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
PreviDent 5000 Sensitive	SODIUM FLUORIDE AND POTASSIUM NITRATE	Colgate Oral Pharmaceuticals, Inc.	b028cfff-4946-49e8-b8bb-197ab99d0d35	2019-12-09	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
6f04db7b-c705-4038-8a35-cd8a62b4bd81			d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	Warnings	Exact identifier spl id: 6f04db7b-c705-4038-8a35-cd8a62b4bd81 spl set id: d142e43f-415a-41c5-a7db-8b18a039a323
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT	SODIUM FLUORIDE	DMG AMERICA, LLC	21fa26f2-0162-4044-aec0-d5360be3f3e0	2019-03-28	Warnings	Exact identifier unii: 8ZYQ1474W7
FLUORIDEX	SODIUM FLUORIDE	DEN-MAT HOLDINGS, LLC.	5fd60635-4b66-15e3-e053-2991aa0ab23a	2019-02-28	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Pro-Den Rx	SODIUM FLUORIDE	Den-mat Holdings, Llc	e39b19f7-2b3e-4c77-9544-623ebad84870	2019-02-28	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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