Colgate Sensitive Complete Protection

Product NDC: 35000-024
11-digit product format: 350000024
Labeler code: 35000
Product ID: 35000-024_0175737b-a121-4537-9dd2-bbfe28b96723
Type: HUMAN OTC DRUG
Nonproprietary name: POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-13
Marketing end: 2027-01-31
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 1.1 mg/g; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	35000-024	35000-024-33	D	Discontinued by firm		2026-10-05

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 · 12 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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 Sensitive Complete Protection

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g
SODIUM FLUORIDE	1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RU45X2JN0Z	Internal UNII lookup
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
1038929	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
4a8f1d2f-b326-46d2-8914-d65ccc409edf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-024-21	Colgate Sensitive Complete Protection	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-024-21	Colgate Sensitive Complete Protection	59 g in 1 TUBE	PASTE, DENTIFRICE	59	10
35000-024-33	Colgate Sensitive Complete Protection	36.8 g in 1 TUBE	PASTE, DENTIFRICE	36.8	10
35000-024-33	Colgate Sensitive Complete Protection	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-024-34	Colgate Sensitive Complete Protection	170 g in 1 TUBE	PASTE, DENTIFRICE	170	10
35000-024-34	Colgate Sensitive Complete Protection	2 in 1 CARTON	PASTE, DENTIFRICE	2	10
35000-024-60	Colgate Sensitive Complete Protection	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-024-60	Colgate Sensitive Complete Protection	170 g in 1 TUBE	PASTE, DENTIFRICE	170	10
35000-024-78	Colgate Sensitive Complete Protection	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-024-78	Colgate Sensitive Complete Protection	22 g in 1 TUBE	PASTE, DENTIFRICE	22	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-024	COLGATE SENSITIVE COMPLETE PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	9	Current NDC, Legacy NDC, 10 package rows	20240207_4a8f1d2f-b326-46d2-8914-d65ccc409edf.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 8 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIGNATURE CARE SORE THROAT CHERRY FLAVOR	PHENOL	SAFEWAY	94a2c1b9-f462-4489-b84a-825a82835d30	2026-02-23	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Meijer, Inc.	c9c17224-9304-403a-b6a1-9c8bd94e3d94	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M022
AQUAFRESH CAVITY PROTECTION	SODIUM FLUORIDE	Haleon US Holdings LLC	5484999c-8e6f-430d-99a5-6893a2489467	2026-02-16	Warnings	Exact identifier application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTION	SODIUM FLUORIDE	Haleon US Holdings LLC	aaff19d9-4ba5-462a-893b-7220feb25d6c	2026-02-16	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Walgreen Co.	55807b18-42ed-45a7-845e-fcf7f5d70d04	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: m022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Walgreen Co.	33223589-4ff4-4e4e-96da-6fa2e4d0f187	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M022
PERIOSCIENCES SENSITIVE AO Pro	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	PERIOSCIENCES LLC	acca8964-b575-468c-8b40-514dfbf50778	2026-02-09	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Retail Business Services, LLC	d46546d0-c6df-431a-8ab0-bc5013c084d7	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	e19228e9-6f87-456e-a222-f979a234d589	2026-02-06	Warnings	Exact identifier application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	49d28991-b68f-ba16-e063-6394a90a0b13	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Strawberry Lemonade	PECTIN	Primrose Candy Co.	49e2b303-1018-cd13-e063-6394a90ae300	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Berry Lemonade	PECTIN	Primrose Candy Co.	49cee56f-c45f-6c79-e063-6294a90a5f8f	2026-02-01	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Rite Aid Corporation	294418aa-640d-42be-ad07-de31da7a7ccc	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	aa61ce6f-8336-4071-93b8-549fd22d1ae0	2026-01-22	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	866067b9-3dce-492d-ae99-1b807ecd56ff	2026-01-22	Warnings	Exact identifier application number: M022
Family Wellness Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR (Family Wellness)	92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea	2026-01-21	Warnings	Exact identifier application number: M022
Crest Pro-Health All Day Clean Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	48eaca4c-19c2-2dd2-e063-6394a90a3e08	2026-01-21	Warnings	Exact identifier application number: M022
Betadine Gargle	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	5f0a3377-1398-2603-c632-f0d214bb88ec	2026-01-21	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Universal Distribution Center LLC	e276ba37-46fb-4ed9-9ee1-c08a2a89704a	2026-01-20	Warnings	Exact identifier application number: M022
Equate Orasol	20% BENZOCAINE	WAL-MART STORES INC.	08404780-8252-4484-b1c3-8970803f74f8	2026-01-19	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	4a8f1d2f-b326-46d2-8914-d65ccc409edf	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-024-21	35000002421	1 TUBE in 1 CARTON (35000-024-21) / 59 g in 1 TUBE	1 tube	2021-04-21	2027-01-31	No	No	Current
35000-024-33	35000002433	1 TUBE in 1 CARTON (35000-024-33) > 36.8 g in 1 TUBE	1 tube	2018-11-13	0000-00-00	No	No	Current
35000-024-34	35000002434	2 TUBE in 1 CARTON (35000-024-34) / 170 g in 1 TUBE	2 tube	2019-02-25	2027-01-31	No	No	Current
35000-024-60	35000002460	1 TUBE in 1 CARTON (35000-024-60) / 170 g in 1 TUBE	1 tube	2019-02-25	2027-01-31	No	No	Current
35000-024-78	35000002478	1 TUBE in 1 CARTON (35000-024-78) / 22 g in 1 TUBE	1 tube	2024-02-06	2027-01-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Sensitive Complete Protection	Colgate-Palmolive Company	2026-01-18	HUMAN OTC DRUG LABEL	11