Colgate

Product NDC: 65954-014
11-digit product format: 659540014
Labeler code: 65954
Product ID: 65954-014_6f04db7b-c705-4038-8a35-cd8a62b4bd81
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Mission Hills S.A de C.V
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-01
Substance: SODIUM FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	65954-014	65954-014-60	D	Discontinued by firm	2026-10-05
excluded package	package	65954-014	65954-014-63	D	Discontinued by firm	2026-10-05
excluded package	package	65954-014	65954-014-75	D	Discontinued by firm	2026-10-05
excluded package	package	65954-014	65954-014-78	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	65954-014-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	65954-014-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	65954-014-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	65954-014-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	65954-014-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	65954-014-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	65954-014-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	65954-014-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	65954-014-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	65954-014-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	65954-014-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	65954-014-63	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	65954-014-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	65954-014-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	65954-014-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	65954-014-63	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	65954-014-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	65954-014-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	65954-014-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	65954-014-63	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	65954-014-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	65954-014-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	65954-014-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	65954-014-63	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	65954-014-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	65954-014-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	65954-014-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	65954-014-63	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	65954-014-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	65954-014-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	65954-014-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	65954-014-63	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	65954-014-75	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	65954-014-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	65954-014-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	65954-014-63	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Colgate
Brand name suffix: Max Fresh Cool Mint
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416783	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d142e43f-415a-41c5-a7db-8b18a039a323	Available on FDA.report

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 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

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	Current NDC, Legacy NDC, 16 package rows	20241127_d142e43f-415a-41c5-a7db-8b18a039a323.zip

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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT	SODIUM FLUORIDE	Colgate-Palmolive Company	b1ef8277-9919-453c-9d21-da4666d952de	2026-09-17	Warnings	Exact identifier application number: M021
TheraBreath	SODIUM FLUORIDE	Church & Dwight Co., Inc.	53c1086d-264b-9d00-e063-6394a90ad19d	2026-09-09	Warnings	Exact identifier application number: M021
Opalescence Whitening Cool Mint	SODIUM FLUORIDE	Ultradent Products, Inc.	44e7d0ed-3c37-5889-e063-6294a90afcca	2026-09-09	Warnings	Exact identifier application number: M021
Opalescence Whitening	SODIUM FLUORIDE	Ultradent Products, Inc	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	2026-09-09	Warnings	Exact identifier application number: M021
Opal by Opalescence Original	SODIUM FLUORIDE	Ultradent Products, Inc.	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	2026-09-09	Warnings	Exact identifier application number: M021
Opal by Opalescence Complete	OPAL BY OPALESCENCE COMPLETE	Ultradent Products, Inc.	249cc46a-dad6-0345-e063-6394a90a4447	2026-09-09	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	Colgate-Palmolive Company	0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9	2026-09-09	Warnings	Exact identifier application number: M021
Colgate MaxFresh Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	de3674f4-3ce6-47d5-8391-6ad6789d68d9	2026-09-09	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity	SODIUM FLUORIDE	New World Imports, Inc	ef108fff-a79c-4e8d-8bf0-3fe567f93eb8	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity	SODIUM FLUORIDE	New World Imports, Inc	1a42cf2d-6c48-4e38-97bc-b6f2084bf39b	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity Gel	SODIUM FLUORIDE	New World Imports, Inc	dfe564c1-2097-431d-93f0-cf423f254248	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	New World Imports, Inc	5aff7e41-58cd-5ab8-e063-6294a90aa1c7	2026-09-08	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Sparkling White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	bc56603d-4190-48c1-b16e-3179a650cb39	2026-09-06	Warnings	Exact identifier application number: M021
Dentalclean Advanced Pro	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	4d261dc8-b065-567f-e063-6294a90aa93f	2026-09-04	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	54bd43c9-489d-4e6b-9031-90ec0e3c4516	2026-09-01	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	53c344e9-49f5-48aa-8309-1e15f80b80a0	2026-09-01	Warnings	Exact identifier application number: M021
Unpaste	ZERO WASTE FLUORIDE MINT TOOTH TABS	Avespan LLC	312ae88d-7ea4-b3e0-e063-6294a90a99e5	2026-09-01	Warnings	Exact identifier application number: M021
Dentalclean Regenerator Sensitive Dental Gel with Fluoride	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	176aa3ed-e2a4-536d-e063-6294a90aa097	2026-08-31	Warnings	Exact identifier application number: M021
Listerine Total Care Fresh Mint Anticavity	SODIUM FLUORIDE	Kenvue Brands LLC	b2ce66c3-dc48-47a5-a731-5550bc194679	2026-08-28	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Your Military Exchanges	cef74e9c-d3b5-4e92-9908-187be97b63ab	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	d142e43f-415a-41c5-a7db-8b18a039a323	16
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	d142e43f-415a-41c5-a7db-8b18a039a323	16
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	d142e43f-415a-41c5-a7db-8b18a039a323	16
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	d142e43f-415a-41c5-a7db-8b18a039a323	16
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	d142e43f-415a-41c5-a7db-8b18a039a323	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65954-014-01	65954001401	1 TUBE in 1 CARTON (65954-014-01) / 28.3 g in 1 TUBE	1 tube	2011-08-01	No	No	Current
65954-014-58	65954001458	1 TUBE in 1 CARTON (65954-014-58) / 70 g in 1 TUBE	1 tube	2011-08-01	No	No	Current
65954-014-60	65954001460	170 g in 1 TUBE	170 g				Historical
65954-014-63	65954001463	1 in 1 CARTON					Historical
65954-014-75	65954001475	79 g in 1 TUBE	79 g				Historical
65954-014-78	65954001478	1 in 1 CARTON					Historical
65954-014-95	65954001495	1 TUBE in 1 CARTON (65954-014-95) / 178 g in 1 TUBE	1 tube	2024-05-28	No	No	Current
65954-014-99	65954001499	1 TUBE in 1 CARTON (65954-014-99) / 53 g in 1 TUBE	1 tube	2011-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Max Fresh ® Cool Mint Fluoride Toothpaste	Mission Hills S.A de C.V \| Colgate-Palmolive Company	2019-04-09	HUMAN OTC DRUG LABEL	16