COLGATE

Product NDC: 65954-041
Requested package NDC: 65954-041-81
11-digit product format: 659540041
Labeler code: 65954
Product ID: 65954-041_30ef40b9-e0d4-49e7-9f38-a3d59e81e80f
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Mission Hills S.A de C.V
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-07-26
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 1 mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65954-041	65954-041-81	D	Discontinued by firm		2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65954-041-81	COLGATEMAX WHITE WITH MINI BRIGHT STRIPS Crystal MINT	130 g in 1 BOTTLE	GEL, DENTIFRICE	130		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65954-041	COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	4	Legacy NDC, 1 package rows	20241020_bfed18c1-8201-46ae-b39c-3d46d4b2fd03.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65954-041-81	65954004181	130 g in 1 BOTTLE (65954-041-81)	130 g	2011-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLGATE ® MAX WHITE ® WITH MINI BRIGHT STRIPS CRYSTAL MINT FLUORIDE TOOTHPASTE	Mission Hills S.A de C.V	2019-04-10	HUMAN OTC DRUG LABEL	4