Colgate Optic White Stain Fighter Sens Relief

Product NDC: 35000-998
11-digit product format: 350000998
Labeler code: 35000
Product ID: 35000-998_53744624-454a-4b7a-b87b-08ea33e238aa
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-11-01
Marketing end: 2027-11-01
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: 1.5; 50 mg/g; mg/g
NDC exclude flag: No
Current FDA listing: Yes

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 Optic White Stain Fighter Sens Relief

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.5 mg/g
POTASSIUM NITRATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup
RU45X2JN0Z	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
6ec2fff7-df44-4302-be2d-97946c6cd66a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-998-60	Colgate Optic White Stain Fighter Sens Relief	1 in 1 CARTON	PASTE, DENTIFRICE	1	8
35000-998-60	Colgate Optic White Stain Fighter Sens Relief	85 g in 1 TUBE	PASTE, DENTIFRICE	85	8
35000-998-71	Colgate Optic White Stain Fighter Sens Relief	1 in 1 CARTON	PASTE, DENTIFRICE	1	8
35000-998-71	Colgate Optic White Stain Fighter Sens Relief	119 g in 1 TUBE	PASTE, DENTIFRICE	119	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-998	COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	8	Current NDC, 4 package rows	20240608_6ec2fff7-df44-4302-be2d-97946c6cd66a.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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lemon Glycerin	GLYCERIN	Dynarex Corporation	99fc00ea-9d55-0380-e053-2995a90a2c0b	2026-03-24	Warnings	Exact identifier application number: M022
Dual-FormulaToothpaste for sensitive teeth	DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH	Hangzhou Namei Zhikang Technology Co., Ltd.	4d735f91-8abc-3a30-e063-6394a90a7639	2026-03-20	Warnings	Exact identifier application number: M022
SmileCare Mouth Ulcer Gel	MENTHOL	Yantai Aien Biotechnology Co., Ltd.	4d6db039-5b97-8f3f-e063-6294a90a9d85	2026-03-19	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f91e609-8ca5-0492-e053-2a95a90a85d0	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f81ffa5-05fd-4eef-e053-2995a90aac3e	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947366-9380-3fa9-e053-2a95a90ad49c	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947672-4873-5546-e053-2a95a90a3c4b	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f9490c1-8bfe-3166-e053-2a95a90a7175	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	2026-03-17	Warnings	Exact identifier application number: M022
BencoCaine Topical Anesthetic	BENZOCAINE	Benco Dental	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	2026-03-17	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043c00a6-1346-7780-e063-6294a90a3d5a	2026-03-12	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	a5f0be98-d47e-4307-8044-304a64db774b	2026-03-11	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	a2f9d58b-671b-4427-a971-1fceff5f2323	2026-03-09	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	a5dbaadf-76a8-4c48-af2d-f4455e9411f0	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Sam's West, Inc	78a3e024-73da-40b7-9d9c-099fd6ca9b9e	2026-03-03	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	CVS PHARMACY, INC	9683bcfb-2f7e-48a4-aa79-500ee8df099a	2026-03-02	Warnings	Exact identifier application number: M022
Spring Gene Oil Pulling Sensitivity	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	294051e3-69ec-4190-8b03-fa34988376b7	2026-02-26	Warnings	Exact identifier application number: M022
Lolleez Watermelon	PECTIN	BFY LLC	4ba8af8b-5a17-8b8c-e063-6394a90a63f3	2026-02-25	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	H E B	f1450866-1be4-46d9-9fe4-52d699636b4f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVOR	PHENOL	SAFEWAY	94a2c1b9-f462-4489-b84a-825a82835d30	2026-02-23	Warnings	Exact identifier application number: M022

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

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	6ec2fff7-df44-4302-be2d-97946c6cd66a	8
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	6ec2fff7-df44-4302-be2d-97946c6cd66a	8
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	6ec2fff7-df44-4302-be2d-97946c6cd66a	8
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	6ec2fff7-df44-4302-be2d-97946c6cd66a	8
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	6ec2fff7-df44-4302-be2d-97946c6cd66a	8
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	6ec2fff7-df44-4302-be2d-97946c6cd66a	8
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	6ec2fff7-df44-4302-be2d-97946c6cd66a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-998-60	35000099860	1 TUBE in 1 CARTON (35000-998-60) / 85 g in 1 TUBE	1 tube	2022-11-01	2027-10-01	No	No	Historical
35000-998-71	35000099871	1 TUBE in 1 CARTON (35000-998-71) / 119 g in 1 TUBE	1 tube	2022-11-01	2027-11-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate Optic White Stain Fighter Sens Relief	Colgate-Palmolive Company \| Mission Hills, S.A. de C.V.	2026-09-08	HUMAN OTC DRUG LABEL	10