Colgate MaxFresh Knockout

Product NDC: 35000-127
11-digit product format: 350000127
Labeler code: 35000
Product ID: 35000-127_aa4c35c1-54b0-42a0-abec-a41932c0821c
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: COLGATE PALMOLIVE COMPANY
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-24
Marketing end: 2026-12-30
Substance: SODIUM FLUORIDE
Active strength: 1.1 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	35000-127	35000-127-60	D	Discontinued by firm		2026-10-20
excluded package	package	35000-127	35000-127-74	D	Discontinued by firm		2026-10-20

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 · 21 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	35000-127-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-127-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-127-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-127-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-127-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-127-74	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-127-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-127-74	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-127-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-127-74	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-127-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-127-74	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-127-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-127-74	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-127-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-127-74	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-127-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-127-74	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	35000-127-74	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	35000-127-74	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	35000-127-74	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 MaxFresh Knockout

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
b6ca4ec7-5087-4693-82b7-199b44d7f931	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-127-30	Colgate MaxFresh Knockout	1 in 1 CARTON	PASTE, DENTIFRICE	1	14
35000-127-30	Colgate MaxFresh Knockout	3 in 1 CELLO PACK	PASTE, DENTIFRICE	3	14
35000-127-60	Colgate MaxFresh Knockout	170 g in 1 TUBE	PASTE, DENTIFRICE	170	14
35000-127-60	Colgate MaxFresh Knockout	1 in 1 CARTON	PASTE, DENTIFRICE	1	14
35000-127-74	Colgate MaxFresh Knockout	1 in 1 CARTON	PASTE, DENTIFRICE	1	14
35000-127-74	Colgate MaxFresh Knockout	182 g in 1 TUBE	PASTE, DENTIFRICE	182	14
35000-127-95	Colgate MaxFresh Knockout	178 g in 1 TUBE	PASTE, DENTIFRICE	178	14
35000-127-95	Colgate MaxFresh Knockout	1 in 1 CARTON	PASTE, DENTIFRICE	1	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-127	COLGATE MAXFRESH KNOCKOUT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]	13	Current NDC, Legacy NDC, 8 package rows	20241115_b6ca4ec7-5087-4693-82b7-199b44d7f931.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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Complete plus Whitening plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c5d5bc17-e81b-34aa-e053-2a95a90ad77f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c5745cc4-213d-1dde-e053-2995a90af562	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Shield	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	960fef18-4533-5250-e053-2995a90aaf76	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c574b51d-07bd-b363-e053-2995a90a7c0e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Blast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d9a1754-8d38-054f-e053-2991aa0a4653	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Breath Purify and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c60fdacf-d997-19a5-e053-2a95a90a96a3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	3d7fffb9-47e0-73cd-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Ultra	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c73ed36a-0e2f-a137-e053-2a95a90a43e0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Extra Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c688d37e-9e80-4599-e053-2a95a90a1916	2026-01-08	Warnings	Exact identifier application number: M021
Crest Gum Detoxify plus Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	63779942-0f6c-11c5-e053-2991aa0a25ab	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Sensitivity Active Foam	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	b8535d1c-cf15-f353-e053-2a95a90a7974	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Extra White Zen Peppermint	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	81279e1f-6224-8114-e053-2991aa0aab08	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c74229c4-b095-df32-e053-2a95a90a4aec	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh Mint	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	c8350ab3-9347-58c0-e053-2995a90a7238	2026-01-08		Exact identifier application number: M021
Crest Premium Plus Anti-Bacterial	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	b7af946e-1cac-b8c0-e053-2a95a90afa4a	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ddcb0871-9900-125f-e053-2a95a90a75de	2026-01-08		Exact identifier application number: M021
Burts Bees Deep Clean plus Whitening	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c924b8dd-8d84-1329-e053-2995a90a4531	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	07ed767e-225c-e9c5-e063-6394a90af931	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	0813171e-bda5-b004-e063-6394a90ad364	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Kids Strawberry Splash	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	087b3434-2636-74ce-e063-6394a90a25ad	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	b6ca4ec7-5087-4693-82b7-199b44d7f931	14
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	b6ca4ec7-5087-4693-82b7-199b44d7f931	14
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	b6ca4ec7-5087-4693-82b7-199b44d7f931	14
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	b6ca4ec7-5087-4693-82b7-199b44d7f931	14
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	b6ca4ec7-5087-4693-82b7-199b44d7f931	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-127-30	35000012730	3 CARTON in 1 CELLO PACK (35000-127-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE	3 carton	2023-07-24	2026-12-30	No	No	Historical
35000-127-60	35000012760	1 TUBE in 1 CARTON (35000-127-60) > 170 g in 1 TUBE	1 tube	2019-10-24	0000-00-00	No	No	Current
35000-127-74	35000012774	1 TUBE in 1 CARTON (35000-127-74) > 182 g in 1 TUBE	1 tube	2020-06-23	2022-12-31	No	No	Current
35000-127-95	35000012795	1 TUBE in 1 CARTON (35000-127-95) / 178 g in 1 TUBE	1 tube	2021-12-01	2026-12-30	No	No	Current