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 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wintergreen Peppermint	POTASSIUM NITRATE, SODIUM FLUORIDE	Twice Twice LLC	7b7beec2-e070-4102-a2a4-68c332fc9fb3	2026-01-19	Warnings	Exact identifier application number: M022
GuruNanda Sensitive	POTASSIUM NITRATE	GURUNANDA, LLC	3ef0d3d4-fd42-0181-e063-6394a90af09c	2026-01-19	Warnings	Exact identifier application number: M022
Up and Up Antiseptic	CETYLPYRIDINIUM CHLORIDE	Target Corporation	386ee9f9-598e-ad00-e063-6394a90aeb46	2026-01-19	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	4a8f1d2f-b326-46d2-8914-d65ccc409edf	2026-01-18	Warnings	Exact identifier application number: M022
Colgate Sensitive Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	3b656928-af58-4ee9-8fb8-360688eb9bf3	2026-01-13	Warnings	Exact identifier application number: M022
Colgate Sensitive Enamel Health	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	a50d4259-8a79-417e-b381-72c7a8ec0418	2026-01-13	Warnings	Exact identifier application number: M022
Walgreens Sensitive Enamel Repair	SODIUM FLUORIDE	Walgreens	41d6384d-695b-b60b-e063-6394a90aa0b9	2026-01-09	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	HY-VEE, INC	47f738cc-7968-cc07-e063-6294a90af7ab	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Clinical White Stain Protector	SODIUM FLUORIDE	CVS Pharmacy	41d5c3a9-abe5-5528-e063-6294a90ada79	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Sensitive Enamel Repair	SODIUM FLUORIDE	CVS	41d547b3-2feb-8e83-e063-6294a90ae3cd	2026-01-09	Warnings	Exact identifier application number: M022
Moon Platinum Advanced Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care LLC	ded3a5a6-2883-f3de-e053-2a95a90afb94	2026-01-09	Warnings	Exact identifier application number: M022
Moon Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0bdcad3e-b8e9-bd91-e063-6394a90a666a	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive Prevent and Repair	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	e67410dc-a671-4611-8af1-097be071cd1c	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive plus Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	2092c747-e025-47a9-9e54-731631d3c831	2026-01-09	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2e7fbf9d-553c-c7bf-e063-6294a90a5f79	2026-01-08	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	47e2650f-4f50-8d85-e063-6394a90a1ddc	2026-01-08	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2b4b22e9-a03b-fb8f-e063-6394a90a8747	2026-01-08	Warnings	Exact identifier application number: M022
Crest 3D White Advanced	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f3aa9a59-b4d4-05d9-e053-2995a90a0aea	2026-01-08		Exact identifier application number: M022
Oral B Plaque Defense Special Care Oral Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d503fad5-a378-0e60-e053-2a95a90abe65	2026-01-08	Warnings	Exact identifier application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d5f69341-b659-c74a-e053-2a95a90a317e	2026-01-08	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