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 34 of 39 · 774 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	b30e4b32-89dd-4e53-81d5-1415105361d4	2024-10-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Efficient Laboratories Inc.	28c5a993-fb5f-4091-af15-32ccae4b9a7d	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Freshmint	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	7e715bb9-666e-4de4-ba70-1c84f5243443	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	2daf18a3-f71e-4585-8128-4663eff7eb6d	2024-10-14	Warnings	Exact identifier application number: M022
Anadent Kanka Gel	BENZOCAINE	BELMORA LLC	e0f73d78-5db1-43b4-8f58-e5410ca4560f	2024-10-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Navajo Manufacturing Company Inc.	f5f26e2f-8a1f-4687-e053-2a95a90ae378	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Navajo Manufacturing Company Inc.	f89bf259-b738-8229-e053-6394a90a0c59	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Navajo Manufacturing Company Inc.	f71c53e0-e2dd-16f9-e053-6394a90accff	2024-10-03	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