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		2026-10-12

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 · 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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	b30e4b32-89dd-4e53-81d5-1415105361d4	2024-10-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Efficient Laboratories Inc.	28c5a993-fb5f-4091-af15-32ccae4b9a7d	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Freshmint	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	7e715bb9-666e-4de4-ba70-1c84f5243443	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	2daf18a3-f71e-4585-8128-4663eff7eb6d	2024-10-14	Warnings	Exact identifier application number: M022
Anadent Kanka Gel	BENZOCAINE	BELMORA LLC	e0f73d78-5db1-43b4-8f58-e5410ca4560f	2024-10-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Navajo Manufacturing Company Inc.	f5f26e2f-8a1f-4687-e053-2a95a90ae378	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Navajo Manufacturing Company Inc.	f89bf259-b738-8229-e053-6394a90a0c59	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Navajo Manufacturing Company Inc.	f71c53e0-e2dd-16f9-e053-6394a90accff	2024-10-03	Warnings	Exact identifier application number: M022
Crest Pro Health	CETYLPYRIDINIUM CHLORIDE	Navajo Manufacturing Company Inc.	65bf17a9-21ad-27cb-e053-2991aa0afc40	2024-10-02	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	94e07979-943b-45bb-8e2b-90d686f3692e	2024-09-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	6eb304dd-2a24-4fa0-9d39-71264e88dd16	2024-08-29	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep Clean	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cfda7efa-86fa-470d-a79f-81907e31778a	2024-08-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Kids Bubble Twist	SODIUM FLUORIDE	Haleon US Holdings LLC	e403529a-0fac-4dab-b75c-46906add096b	2024-08-13	Warnings	Exact identifier application number: M022
Calcium Carbonate Assorted Flavors	ANTACID TABLETS	NuCare Pharmaceuticals,Inc.	af10dfb6-fef3-3410-e053-2995a90a9130	2024-07-17	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening Plus	POTASSIUM NITRATE	Haleon US Holdings LLC	f757ccdd-b316-4799-a34a-10edbb73da6b	2024-07-12	Warnings	Exact identifier application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE, SODIUM FLUORIDE	Lidl US, LLC	baef7f15-8082-4e61-8c08-8beda8ad40c0	2024-07-03	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