Colgate Triple Action

Product NDC: 35000-941
11-digit product format: 350000941
Labeler code: 35000
Product ID: 35000-941_905181e2-96e2-4b14-9605-47353a251173
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: 2010-12-01
Substance: SODIUM FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	35000-941	35000-941-46	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-47	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-63	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-64	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-79	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-82	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-92	D	Discontinued by firm	2026-10-16
excluded package	package	35000-941	35000-941-99	D	Discontinued by firm	2026-10-16

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 · 46 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	35000-941-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-941-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-941-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-941-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-941-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-941-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-941-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-941-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-941-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-941-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-941-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-941-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-941-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-941-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-941-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-941-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-941-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-941-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-941-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-941-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-941-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-941-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-941-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-941-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-941-82	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-941-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-941-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-941-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-941-79	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-941-82	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-941-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-941-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-941-46	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-941-79	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-941-82	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-941-64	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-941-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-941-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-941-79	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-941-82	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-941-64	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-941-92	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-941-46	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-941-79	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-941-82	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-941-64	`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 Triple Action
Listing expiration: 2027-12-31

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
3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	Available on FDA.report

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
35000-941-30	Colgate Triple Action	3 in 1 CARTON	PASTE, DENTIFRICE	3	10
35000-941-30	Colgate Triple Action	170 g in 1 TUBE	PASTE, DENTIFRICE	170	10
35000-941-46	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-46	Colgate Triple Action	130 g in 1 TUBE	PASTE, DENTIFRICE	130	10
35000-941-47	Colgate Triple Action	133 g in 1 TUBE	PASTE, DENTIFRICE	133	10
35000-941-47	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-48	Colgate Triple Action	226 g in 1 TUBE	PASTE, DENTIFRICE	226	10
35000-941-48	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-58	Colgate Triple Action	70 g in 1 TUBE	PASTE, DENTIFRICE	70	10
35000-941-58	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-60	Colgate Triple Action	170 g in 1 TUBE	PASTE, DENTIFRICE	170	10
35000-941-60	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-63	Colgate Triple Action	85 g in 1 TUBE	PASTE, DENTIFRICE	85	10
35000-941-63	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-64	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-64	Colgate Triple Action	181 g in 1 TUBE	PASTE, DENTIFRICE	181	10
35000-941-69	Colgate Triple Action	113 g in 1 TUBE	PASTE, DENTIFRICE	113	10
35000-941-69	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-79	Colgate Triple Action	79 g in 1 TUBE	PASTE, DENTIFRICE	79	10
35000-941-79	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-82	Colgate Triple Action	232 g in 1 TUBE	PASTE, DENTIFRICE	232	10
35000-941-82	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-92	Colgate Triple Action	141 g in 1 TUBE	PASTE, DENTIFRICE	141	10
35000-941-92	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-99	Colgate Triple Action	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-941-99	Colgate Triple Action	99 g in 1 TUBE	PASTE, DENTIFRICE	99	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-941	COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]	7	Current NDC, Legacy NDC, 26 package rows	20241127_3082e9ba-66d9-4fc7-bbe6-b41b60939bd2.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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Murchison Hume Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	b1a442e1-86cf-cba6-e053-2995a90a593a	2023-12-20	Warnings	Exact identifier application number: M021
United Airlines Polaris Kit with Colgate	SODIUM MONOFLUOROPHOSPHATE	Buzz Export Services Pty Ltd (Buzz Products)	de4564a4-1012-baad-e053-2a95a90a11b7	2023-12-20	Warnings	Exact identifier application number: M021
Orajel Complete Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	daebd16f-d278-446d-8b7a-33add5a74fdd	2023-12-19	Warnings	Exact identifier application number: M021
Orajel Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	Church & Dwight Co., Inc.	7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb	2023-12-19	Warnings	Exact identifier application number: M021
ORTHO GUARD	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	2023-12-17	Warnings	Exact identifier application number: M021
Beyond Activated Coconut Charcoal and Sea Salt	SODIUM FLUORIDE	Beyond International Inc	d075fa15-7309-0c10-e053-2995a90a7c95	2023-11-28	Warnings	Exact identifier application number: M021
Pro-Den Rx	STANNOUS FLUORIDE	Den-mat Holdings, Llc	9036aa8a-59b1-41b0-b3cb-529d3303a1c0	2023-11-20	Warnings	Exact identifier application number: M021
Fluoridex	STANNOUS FLUORIDE RINSE	DEN-MAT HOLDINGS, LLC	5e81f073-c0ca-aa38-e053-2a91aa0ab37b	2023-11-20	Warnings	Exact identifier application number: M021
Hello Vitamin C Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	38a0276e-910c-527d-1736-65928b9d4ca4	2023-11-20	Warnings	Exact identifier application number: M021
POP Feeling Peachy	SODIUM FLUORIDE	LG H&H CO., LTD.	0abaf99b-9547-46ae-e063-6394a90a6c15	2023-11-17	Warnings	Exact identifier application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	e3356374-befa-41b0-ab0f-edfd5a062601	2023-11-16	Warnings	Exact identifier application number: M021
ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	421fc2f0-b118-4e7a-a399-ba4780028c54	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Universal Distribution Center LLC	3411924d-1002-460c-83e8-c0c7fbff9ad1	2023-11-16	Warnings	Exact identifier application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	879dfaf0-27c8-41a3-8d01-a1c3eec9edfc	2023-11-15	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	0989936c-237d-dc63-e063-6294a90a885f	2023-11-07	Warnings	Exact identifier application number: M021
Eurofresh Whitening	SODIUM FLUORIDE	Farmasi US LLC	b56b2b55-e3a4-785a-e053-2a95a90a7abf	2023-11-05	Warnings	Exact identifier application number: M021
Farmasi Whitening	SODIUM FLUORIDE	Farmasi US LLC	25b3608e-abed-41ca-9971-21981b8a4610	2023-11-05	Warnings	Exact identifier application number: M021
United Airlines Therabody UPP Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	fb6c355b-a67d-c4b4-e053-6394a90a0e66	2023-10-26	Warnings	Exact identifier application number: M021
United Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	7f348fe7-9918-4934-bed0-f0a77c09d046	2023-10-26	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	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	10
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	10
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	10
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	10
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-941-30	35000094130	3 TUBE in 1 CARTON (35000-941-30) / 170 g in 1 TUBE	3 tube	2025-01-01		No	No	Current
35000-941-46	35000094146	1 TUBE in 1 CARTON (35000-941-46) > 130 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-47	35000094147	1 TUBE in 1 CARTON (35000-941-47) > 133 g in 1 TUBE	1 tube	2020-12-14	0000-00-00	No	No	Current
35000-941-48	35000094148	1 TUBE in 1 CARTON (35000-941-48) / 226 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-58	35000094158	1 TUBE in 1 CARTON (35000-941-58) / 70 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-60	35000094160	1 TUBE in 1 CARTON (35000-941-60) / 170 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-63	35000094163	1 TUBE in 1 CARTON (35000-941-63) > 85 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-64	35000094164	1 TUBE in 1 CARTON (35000-941-64) > 181 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-69	35000094169	1 TUBE in 1 CARTON (35000-941-69) / 113 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-79	35000094179	1 TUBE in 1 CARTON (35000-941-79) > 79 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-82	35000094182	1 TUBE in 1 CARTON (35000-941-82) > 232 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-92	35000094192	1 TUBE in 1 CARTON (35000-941-92) > 141 g in 1 TUBE	1 tube	2010-12-01	0000-00-00	No	No	Current
35000-941-99	35000094199	1 TUBE in 1 CARTON (35000-941-99) > 99 g in 1 TUBE	1 tube	2020-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Triple Action Fluoride Toothpaste	Colgate-Palmolive Company \| Mission Hills, S.A. de C.V.	2026-07-08	HUMAN OTC DRUG LABEL	16