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	2026-10-15
excluded package	package	65954-014	65954-014-63	D	Discontinued by firm	2026-10-15
excluded package	package	65954-014	65954-014-75	D	Discontinued by firm	2026-10-15
excluded package	package	65954-014	65954-014-78	D	Discontinued by firm	2026-10-15

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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro Health Sensitive and Enamel Shield	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb48b15c-f821-e5cd-e053-6294a90ac64c	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Luminous Purple	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	fbfcd837-4d88-5f82-e053-6394a90afbf6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health with a Touch of Scope	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb572b41-36cd-55d7-e053-6394a90a71c8	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Whitening Gel	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb5b1e94-bed6-8486-e053-6294a90a3a84	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Ultra Vivid Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	cba96ef0-0519-059f-e053-2a95a90a43ad	2026-01-08	Warnings	Exact identifier application number: M021
Crest 4in1	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ce545406-3c4f-1ba7-e053-2a95a90a91ac	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d218ddc0-1d5f-f39b-e053-2995a90a96ed	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Antibacterial Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d58bc842-2687-e52d-e053-2995a90a5433	2026-01-08	Warnings	Exact identifier application number: M021
Scope Stay Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d65b3153-2026-a8c0-e053-2a95a90a31d6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Whitening Charcoal	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d6f68485-b92f-41c7-e053-2995a90a4fe5	2026-01-08	Warnings	Exact identifier application number: M021
KIDS Crest Advanced Enamel Plus Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d837ecde-249a-7868-e053-2a95a90a56ae	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Whitening Intensive Cleaning	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d6fa4187-a651-647b-e053-2995a90a8567	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Gum Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d7729dde-c828-34e6-e053-2a95a90a5ee6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Densify Daily Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d811306f-4994-7a5a-e053-2995a90adf16	2026-01-08	Warnings	Exact identifier application number: M021
Crest Densify Daily Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d810d4e5-ba66-efe1-e053-2995a90abfc0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Braces Care Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d823cba4-c4cf-7d7a-e053-2995a90a01f0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Sensitive Relief	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d7730674-7513-52cf-e053-2995a90ab32c	2026-01-08	Warnings	Exact identifier application number: M021
Kids Crest Bubblegum Flavor	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	26a7a892-5da4-4749-bbb6-566efab7d749	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	8c91095d-88c0-4d22-a79a-7d0f0d05302b	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Deep Clean Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d774295f-8ebd-9877-e053-2a95a90a9a0e	2026-01-08	Warnings	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