Colgate

Product NDC: 35000-903
Requested package NDC: 35000-903-01
11-digit product format: 350000903
Labeler code: 35000
Product ID: 35000-903_14f9feea-6d53-476e-84c5-4a6cabd5c0ac
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
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: 2027-12-31
Current FDA listing: Yes

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: 2027-12-31

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
00652bb2-090c-4eaa-8fc2-e0be6913a724	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-903-01	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-01	ColgateMax Fresh Cool Mint	28.3 g in 1 TUBE	GEL, DENTIFRICE	28.3	6
35000-903-58	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-58	ColgateMax Fresh Cool Mint	70 g in 1 TUBE	GEL, DENTIFRICE	70	6
35000-903-60	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-60	ColgateMax Fresh Cool Mint	170 g in 1 TUBE	GEL, DENTIFRICE	170	6
35000-903-75	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-75	ColgateMax Fresh Cool Mint	79 g in 1 TUBE	GEL, DENTIFRICE	79	6
35000-903-78	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-78	ColgateMax Fresh Cool Mint	221 g in 1 TUBE	GEL, DENTIFRICE	221	6
35000-903-95	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-95	ColgateMax Fresh Cool Mint	178 g in 1 TUBE	GEL, DENTIFRICE	178	6
35000-903-99	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	6
35000-903-99	ColgateMax Fresh Cool Mint	53 g in 1 TUBE	GEL, DENTIFRICE	53	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-903	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	4	Current NDC, Legacy NDC, 14 package rows	20241127_00652bb2-090c-4eaa-8fc2-e0be6913a724.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 22 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prime Tooth Care Mango Smoothie	SODIUM FLUORIDE	Prime Tooth Care LLC	2f2cf851-2edc-4aaf-9083-c37bc58547de	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Strawberries	SODIUM FLUORIDE	Prime Tooth Care LLC	7b4328bd-5d2d-40ca-8322-5e818e1babf9	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Summer Watermelon	SODIUM FLUORIDE	Prime Tooth Care LLC	b7c731a1-80e7-4571-a568-db0290a720c1	2026-01-09	Warnings	Exact identifier application number: M021
Kids Prime Pediatric Dental Group Anticavity for Kids	SODIUM FLUORIDE	Prime Tooth Care LLC	93259174-447d-4f7a-8e55-990eb8da5151	2026-01-09	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Enamel Protect	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f32d5708-8cb1-6499-e053-2995a90ac632	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Complete Care Anticavity Fluoride	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f3a644c0-da04-276d-e053-2a95a90abf27	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Active Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4487d78-1da8-3f33-e053-2a95a90a6d92	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Sensitive Care	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f435c1fe-7fbb-1b25-e053-2995a90aca11	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Pro Intensive Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f45c9c89-f294-deca-e053-2a95a90ae557	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a00de-b16a-66e6-e053-2995a90aedc6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Gentle Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a7dc7-77f3-3911-e053-2a95a90ad55c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	961295a6-79ae-44b1-e053-2995a90a6130	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Intensive Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2118d-1216-d0d0-e053-2995a90a7088	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	96247083-39e9-7ca7-e053-2995a90a75d0	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Express White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2d5aa-b0e6-7068-e053-2995a90ae90c	2026-01-08	Warnings	Exact identifier application number: M021
Crest complete plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	973ce138-c64e-c059-e053-2a95a90a3148	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c3ad36-72d8-16e8-e053-2a95a90a8702	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d65b58-9818-820d-e053-2995a90a9f00	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitive and Gum All Day Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d775a1-a4f6-cd69-e053-2995a90a5f64	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Advanced Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4ead762-17b2-22a0-e053-2a95a90ac866	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	00652bb2-090c-4eaa-8fc2-e0be6913a724	6
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	00652bb2-090c-4eaa-8fc2-e0be6913a724	6
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	00652bb2-090c-4eaa-8fc2-e0be6913a724	6
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	00652bb2-090c-4eaa-8fc2-e0be6913a724	6
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	00652bb2-090c-4eaa-8fc2-e0be6913a724	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-903-01	35000090301	1 TUBE in 1 CARTON (35000-903-01) / 28.3 g in 1 TUBE	1 tube	2020-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Max Fresh ® Cool Mint Fluoride Toothpaste	Colgate-Palmolive Company \| Mission Hills, S.A. de C.V.	2026-07-22	HUMAN OTC DRUG LABEL	8