Sensodyne Pronamel

Product NDC: 0135-0810
Requested package NDC: 0135-0810-01
11-digit product format: 001350810
Labeler code: 0135
Product ID: 0135-0810_1fab5aa6-1081-c4f5-e063-6294a90a5d1c
Type: HUMAN OTC DRUG
Nonproprietary name: potassium nitrate, sodium fluoride
Dosage form: PASTE
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-06
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 1.15 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 Pronamel
Brand name suffix: Clinical Enamel Strength Deep Clean
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g
SODIUM FLUORIDE	1.15 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
1086243	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
cfda7efa-86fa-470d-a79f-81907e31778a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0810-01	Sensodyne PronamelClinical Enamel Strength Deep Clean	23 g in 1 TUBE	PASTE	23	1
0135-0810-02	Sensodyne PronamelClinical Enamel Strength Deep Clean	1 in 1 CARTON	PASTE	1	1
0135-0810-02	Sensodyne PronamelClinical Enamel Strength Deep Clean	96.4 g in 1 TUBE	PASTE	96.4	1
0135-0810-03	Sensodyne PronamelClinical Enamel Strength Deep Clean	1 in 1 CARTON	PASTE	1	1
0135-0810-03	Sensodyne PronamelClinical Enamel Strength Deep Clean	65.2 g in 1 TUBE	PASTE	65.2	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0810	SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH DEEP CLEAN (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	1	Current NDC, 5 package rows	20250107_cfda7efa-86fa-470d-a79f-81907e31778a.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 24 of 39 · 779 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	f2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart	STANNOUS FLUORIDE	Burkhart Dental Supply Inc	6d8078e9-b0d8-4220-b90a-3f14fa0e43f4	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	26128466-939b-445f-aa64-04c7283d306c	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart	STANNOUS FLUORIDE	Burkhart Dental Supply Inc	048c9978-e32e-4f77-9a4e-40acd5fcdfaf	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	aa09dcc0-e641-4c6d-8a84-ba890c0fce4c	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	4255da05-d264-4a4c-bd67-53d4862c0682	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	2282ea74-94c1-40be-a77f-290763a76250	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	99bce4c6-4593-40a1-b28d-8334a79b9d42	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	aa233c68-c6ac-44a5-b50e-3f5cd843bd25	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	bb11bfb4-1b50-48c6-8273-452b47b47833	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	867cef7b-fe6e-4a45-87c1-35579a681c6c	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	c6238079-0bcc-4c35-9b73-455252d41ee5	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	b144aca9-91d1-4106-a39c-b928192ad41e	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	0192ccf9-1715-4e23-a6bf-8bd838cd8b0d	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	edcb8451-6fa7-4bc2-95f6-2a0806f7f3da	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	576660ed-203a-4842-9d39-c5be10daf976	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	1796b3ec-833a-4cf1-ba50-bc4da827f84f	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	d923fa75-f556-45e3-9f52-39a62e89984b	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	cd3ede8c-2c77-4d81-8dff-8198025a2156	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f5f9b-4192-15e6-e053-2995a90a6457	2025-01-09	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
1086243	potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste	PSN	cfda7efa-86fa-470d-a79f-81907e31778a	1
1086243	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste	SCD	cfda7efa-86fa-470d-a79f-81907e31778a	1
1086243	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY	cfda7efa-86fa-470d-a79f-81907e31778a	1
1086243	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY	cfda7efa-86fa-470d-a79f-81907e31778a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0135-0810-01	00135081001	23 g in 1 TUBE (0135-0810-01)	23 g	2025-01-06	No	No	Current