Colgate Optic White Stain Fighter Clean Mint

Product NDC: 65954-403
11-digit product format: 659540403
Labeler code: 65954
Product ID: 65954-403_65479920-a47f-498a-96dd-48f61d98948b
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Mission Hills S.A de C.V
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-11-30
Marketing end: 2027-10-27
Substance: SODIUM FLUORIDE
Active strength: 1 mg/g
NDC exclude flag: No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	65954-403	65954-403-02	D	Discontinued by firm	2026-10-15
excluded package	package	65954-403	65954-403-30	D	Discontinued by firm	2026-10-15
excluded package	package	65954-403	65954-403-33	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`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 Optic White Stain Fighter Clean Mint

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
65954-403-02	Colgate Optic White Stain Fighter Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	7
65954-403-02	Colgate Optic White Stain Fighter Clean Mint	56.6 g in 1 TUBE	PASTE, DENTIFRICE	56.6	7
65954-403-30	Colgate Optic White Stain Fighter Clean Mint	85 g in 1 TUBE	PASTE, DENTIFRICE	85	7
65954-403-30	Colgate Optic White Stain Fighter Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	7
65954-403-33	Colgate Optic White Stain Fighter Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	7
65954-403-33	Colgate Optic White Stain Fighter Clean Mint	36.8 g in 1 TUBE	PASTE, DENTIFRICE	36.8	7
65954-403-60	Colgate Optic White Stain Fighter Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	7
65954-403-60	Colgate Optic White Stain Fighter Clean Mint	170 g in 1 TUBE	PASTE, DENTIFRICE	170	7
65954-403-71	Colgate Optic White Stain Fighter Clean Mint	119 g in 1 TUBE	PASTE, DENTIFRICE	119	7
65954-403-71	Colgate Optic White Stain Fighter Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65954-403	COLGATE OPTIC WHITE STAIN FIGHTER CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]	7	Current NDC, Legacy NDC, 10 package rows	20241127_1726a2d2-8580-4059-81ec-bbfb3af79492.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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	b9e6e455-8444-4805-89f1-ee9142f98e36	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	7db8e49d-1073-4a81-a3a4-f3a19ebce921	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	1fe50b49-bc62-4137-866c-e87bb878a96d	2026-08-10	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Radiant White	FLUORIDE	Lornamead Products	f0b62aaa-4983-4bd3-931e-f1a31b870f62	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Stain Prevention	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	76df52a3-b24c-4009-8137-fe644dabebf6	2026-07-29	Warnings	Exact identifier application number: M021
Colgate Kids Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	f0e68196-8566-443b-9cc8-b57d5c001558	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Vividly Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f0551acf-c4d6-4d49-ae9c-4aeaeb99a700	2026-07-29	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Whitening KnockOut Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	92079d13-3b66-42b7-9990-2727a489b6f6	2026-07-28	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	7d04d050-b283-4fce-b1e9-e695b70363f9	2026-07-27	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd805999-86e4-4f6c-9889-fa9a2227d526	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	913a2cd6-b6a8-4069-979f-3c696a9bfdf0	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PURPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	16e9b303-fc2a-451a-adc7-dcb10fc0e6f8	2026-07-23	Warnings	Exact identifier application number: M021
Orajel Kids Superman	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	2b47af33-32d4-7c06-e063-6394a90a2f33	2026-07-23	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	1726a2d2-8580-4059-81ec-bbfb3af79492	7
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	1726a2d2-8580-4059-81ec-bbfb3af79492	7
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	1726a2d2-8580-4059-81ec-bbfb3af79492	7
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	1726a2d2-8580-4059-81ec-bbfb3af79492	7
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	1726a2d2-8580-4059-81ec-bbfb3af79492	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65954-403-02	65954040302	1 in 1 CARTON						Historical
65954-403-30	65954040330	85 g in 1 TUBE	85 g					Historical
65954-403-33	65954040333	1 in 1 CARTON						Historical
65954-403-60	65954040360	1 TUBE in 1 CARTON (65954-403-60) / 170 g in 1 TUBE	1 tube	2018-12-19	2027-10-27	No	No	Historical
65954-403-71	65954040371	1 TUBE in 1 CARTON (65954-403-71) / 119 g in 1 TUBE	1 tube	2017-11-30	2027-10-02	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Optic White ® Stain Fighter™ Clean Mint	Mission Hills S.A de C.V	2026-09-18	HUMAN OTC DRUG LABEL	8