Sensodyne

Product NDC: 0135-0550
11-digit product format: 001350550
Labeler code: 0135
Product ID: 0135-0550_187e31fd-385b-91a4-e063-6394a90a9b1d
Type: HUMAN OTC DRUG
Nonproprietary name: potassium nitrate and sodium fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: Haleon US Holdings LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-02-17
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 1.1 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Sensodyne
Listing expiration: 2026-12-31

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
1038841	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
9e8e7b9f-3ccd-4935-b886-93f3a5045b67	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0135-0550-04	Sensodyne	1 in 1 CARTON	PASTE	1		10
0135-0550-04	Sensodyne	113 g in 1 TUBE	PASTE	113		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM NITRATE	ACTIVE INGREDIENT	RU45X2JN0Z	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SODIUM METHYL COCOYL TAURATE	INACTIVE INGREDIENT	JVL98CG53G	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SODIUM TRIPOLYPHOSPHATE ANHYDROUS	INACTIVE INGREDIENT	9SW4PFD2FZ	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0550	SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240516_9e8e7b9f-3ccd-4935-b886-93f3a5045b67.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
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
1038841	potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste	PSN	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	10
1038841	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG Toothpaste	SCD	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	10
1038841	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste	SY	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	10
1038841	pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel Toothpaste	SY	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	10
1038841	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste	SY	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	10
1038841	potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste	SY	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0550-04	00135055004	1 TUBE in 1 CARTON (0135-0550-04) / 113 g in 1 TUBE	1 tube	2004-02-17	0000-00-00	No	No	Current