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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moon Charcoal Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c55f7b3-fea1-58f3-e063-6394a90a3bde	2023-12-12	Warnings	Exact identifier application number: M022
ORCA Complete Menthol Pain Reliever	MENTHOL	ORCA Products, LLC	99990e27-d66b-4d61-97f2-6a76066eb8b8	2023-12-08	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	0070858b-e02e-431f-a7c2-313fef01791b	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	d1802f08-80cb-41dd-b34d-9c576b101ddb	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	80182c43-100f-4b15-a07e-819599ab9562	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c19e6426-8f1e-47b3-a3a6-551a5bec6cd9	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1f8431bb-f33c-4fd8-9472-9b59ffb5f18e	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1163d248-d648-443e-bed0-ccb7fd26ba63	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	88caabe2-a096-44d0-98d3-afad1935c012	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c1b02a2f-db1f-44f0-a74a-d02c085c5bd7	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	39081585-fe6a-4ba1-93f8-d92d26fe75bc	2023-12-07	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d7c69357-795c-03d8-e053-2a95a90a03a6	2023-12-06	Warnings	Exact identifier application number: M022
Dr. Sheffield Sensitive Care	SENSITIVE TOOTH PASTE	Sheffield Pharmaceuticals LLC	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	2023-11-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f3bf106c-5320-ced2-e053-2a95a90a71ac	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b517321-25ed-2676-e063-6294a90ab4c9	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b51b67c-03ac-5730-e063-6394a90a5060	2023-11-29	Warnings	Exact identifier application number: M022
Pearl White	POTASSIUM NITRATE, SODIUM FLUORIDE	Beyond International Inc.	51c79544-9536-5863-e054-00144ff8d46c	2023-11-28	Warnings	Exact identifier application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE AND SODIUM FLUORIDE	Universal Distribution Center LLC	fcf59439-7e06-4129-a89f-cdeecdf8d488	2023-11-17	Warnings	Exact identifier application number: M022
PerioRestore	HYDROGEN PEROXIDE	DEN-MAT HOLDINGS, LLC.	97a07c36-1af8-a636-e053-2a95a90ad6db	2023-11-13	Warnings	Exact identifier application number: M022
Wild Horse 777 Oral	PHENOL	Wild Horse 777, Inc.	b0b517bb-969f-0c65-e053-2995a90a48b1	2023-11-10	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