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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CrystLCare Regeneration Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	GreenMark Biomedical Inc.	4f86d0a0-d73e-5605-e063-6394a90adb38	2026-09-14	Warnings	Exact identifier application number: M022
Opalescence Whitening Sensitivity Relief	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	44e94663-895b-67da-e063-6394a90a5fe6	2026-09-09	Warnings	Exact identifier application number: M022
Opalescence Sensitivity Relief Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	b5176a84-76a3-4ad0-a2e2-4997a12da9a5	2026-09-09	Warnings	Exact identifier application number: M022
Opal by Opalescence Sensitivity	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	5ffc0d14-0290-47bb-90e5-90a25a5acc28	2026-09-09	Warnings	Exact identifier application number: M022
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier application number: M022
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier application number: M022
Colgate Optic White Stain Fighter Sens Relief	SODIUM FLUORIDE	Colgate-Palmolive Company	6ec2fff7-df44-4302-be2d-97946c6cd66a	2026-09-08	Warnings	Exact identifier application number: M022
DRx Choice Sore Throat Menthol Flavor	PHENOL	RARITAN PHARMACEUTICALS INC	e3269b12-5c05-45a6-81f2-65d9f016c3aa	2026-09-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	0733015b-e81a-4a62-82ad-dacaf3f163cb	2026-09-02	Warnings	Exact identifier application number: M022
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT	HEXYLRESORCINOL	Reckitt Benckiser LLC	91cd2964-5d83-4e40-bc18-e3e5462f454a	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier application number: M022
LUDENS SUGAR FREE WILD CHERRY THROAT	PECTIN	Prestige Brands Holdings, Inc.	274fc80c-e5b2-41c7-a119-287d6e8a2258	2026-08-28	Warnings	Exact identifier application number: M022
Medline Peroxi Fresh Mouthwash	HYDROGEN PEROXIDE	Medline Industries, LP	ec7a9240-6c66-4471-b8b6-776e08a14fbc	2026-08-27	Warnings	Exact identifier application number: M022
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	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