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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Cavity Protection Great Regular Flavor	ANTICAVITY FLUORIDE TOOTHPASTE	Colgate-Palmolive Company	202c6c62-e16a-4716-babe-d5414006c79e	2026-01-21	Warnings	Exact identifier application number: M021
Crest 3D White Luxe Diamond Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c1420129-5460-4900-ac9a-356d2d7c60a2	2026-01-21	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion Prevention	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	48eb0bdc-7399-745d-e063-6294a90a9809	2026-01-21	Warnings	Exact identifier application number: M021
Colgate Total Gum Protect Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	dcf81dcb-b26b-4411-82d4-5f7e9d3fc0f3	2026-01-20	Warnings	Exact identifier application number: M021
GuruNanda Anti-Cavity	SODIUM FLUORIDE	GURUNANDA, LLC	3b07b72f-4efc-eb0f-e063-6294a90a70a8	2026-01-19	Warnings	Exact identifier application number: M021
GuruNanda Anticavity	SODIUM FLUORIDE	GURUNANDA, LLC	3e90d516-3172-3c8d-e063-6294a90a394f	2026-01-19	Warnings	Exact identifier application number: M021
Hismile	PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0eba92d1-cbdc-9c96-e063-6294a90a9afc	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef3cfb6-6bae-1682-e063-6394a90aca88	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef3f4f8-fdc4-2056-e063-6394a90a6fd7	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef41051-dfa0-b105-e063-6294a90a551f	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef43107-58ec-d4ee-e063-6294a90ad8d7	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef56539-dc21-c6ea-e063-6394a90a5790	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef6f8b5-8565-b364-e063-6294a90aabbc	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef766ae-754a-f185-e063-6294a90a3299	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef7be5b-df8f-9f32-e063-6394a90a4724	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef8d0ef-a051-f610-e063-6394a90a8537	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d40b98b-2e9a-d84a-e063-6294a90a2096	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d44863e-93be-2b80-e063-6294a90a4a9d	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d458ccc-8f1e-f9c8-e063-6294a90a8da4	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d447939-fbf6-42f6-e063-6294a90af6d9	2026-01-15	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