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		2026-10-12
excluded package	package	35000-127	35000-127-74	D	Discontinued by firm		2026-10-12

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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate MaxFresh Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	7cb85fc4-573b-45d7-a430-f2fd17320c43	2026-08-26	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	8b210b6c-b712-4f14-906c-306922573a26	2026-08-26	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	59dff762-7f66-8bdc-e063-6294a90a9f18	2026-08-25	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Nice-Pak Products, LLC	c71d4064-f938-477b-9346-eb38be65390d	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M021
AIM Whitening with Baking Soda	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fd0b4-33ba-5764-e054-00144ff88e88	2026-08-25	Warnings	Exact identifier application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEAN	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	b1ada157-a9a0-4eec-83a2-6e448d7f12dc	2026-08-21	Warnings	Exact identifier application number: M021
Therabreath Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3ba04b55-38f9-76f3-e063-6394a90a3c03	2026-08-21	Warnings	Exact identifier application number: M021
Therabreath Deep Clean	STANNOUS FLUORIDE	Church & Dwight Co., Inc.	3c372f26-e0c4-0659-e063-6294a90ae9f9	2026-08-21	Warnings	Exact identifier application number: M021
TheraBreath	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b812a38-f7cb-51c8-e063-6394a90ab82c	2026-08-21	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	eb95e0ca-a94c-41cb-9f54-6c64ed9a9733	2026-08-21	Warnings, Adverse reactions	Exact identifier application number: M021
Pop On Toothpaste.	POP ON TOOTHPASTE.	POPONSMILES,LLC	4a0edab5-ae36-91b5-e063-6294a90aa685	2026-08-21	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	188dc3ac-64c9-438e-858b-846f725c6ea0	2026-08-21	Warnings	Exact identifier application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT	STANNOUS FLUORIDE	Colgate-Palmolive Company	178d4535-fa57-4b53-b1f8-5c591f2ea9e7	2026-08-21	Warnings	Exact identifier application number: M021
freshSTART Anticavity fluoride toothpaste.	ANTICAVITY FLUORIDE TOOTHPASTE	Guangzhou Xinuo Technology Co., Ltd.	596432d5-3541-6dff-e063-6294a90a9d42	2026-08-19	Warnings	Exact identifier application number: M021
Colgate Sensitive ProRelief Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	8d9d485e-6efb-4bca-a779-9e8b0aeed14c	2026-08-18	Warnings	Exact identifier application number: M021
SprinJene Natural	SODIUM MONOFLUOROPHOSPHATE	Health and Natural Beauty USA Corp	e64cecc3-0845-4bdf-a449-d78248791ccf	2026-08-17	Warnings	Exact identifier application number: M021
ATOMY ANTICAVITY TOOTH	SODIUM MONOFLUOROPHOSPHATE	ATOMY CO., LTD.	592caccc-e3a9-9c66-e063-6394a90a26e3	2026-08-16	Warnings	Exact identifier application number: M021
SprinJene Health Boost	SODIUM MONOFLUOROPHOSPHATE	Health and Natural Beauty USA Corp	9be87bcd-403a-4d7e-8ded-9833249565d1	2026-08-14	Warnings	Exact identifier application number: M021
SprinJene Fresh Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	919f6f51-6c43-4f1c-9bc7-029bf76c0e68	2026-08-14	Warnings	Exact identifier application number: M021
SprinJene Natural Sensitivity Relief	SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE	Health and Natural Beauty USA Corp	32cc5bc2-60c9-4cb4-acde-485ae494aba2	2026-08-14	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