SENSODYNE PRONAMEL

Product NDC: 0135-0451
11-digit product format: 001350451
Labeler code: 0135
Product ID: 0135-0451_0a03a9b2-cbbd-4b73-91db-aea9d3a32264
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride
Dosage form: LIQUID
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-02
Substance: SODIUM FLUORIDE
Active strength: .5 mg/mL
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: Intensive Enamel Repair Extra Fresh
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
240698	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
817c0dad-d109-428e-adb5-3354604acc94	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0135-0451-01	SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh	500 mL in 1 BOTTLE	LIQUID	500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0451	SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT (SODIUM FLUORIDE) LIQUID SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH (SODIUM FLUORIDE) LIQUID [HALEON US HOLDINGS LLC]	3	Current NDC, 1 package rows	20241030_817c0dad-d109-428e-adb5-3354604acc94.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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GuruNanda Oxyfusion	HYDROGEN PEROXIDE	GURUNANDA, LLC	3be317b9-a5d8-b198-e063-6394a90af985	2025-11-11	Warnings	Exact identifier application number: M022
GuruNanda Oral Pain Relief	MENTHOL	GURUNANDA, LLC	3b8f3562-0e46-bea4-e063-6294a90adb71	2025-11-11	Warnings	Exact identifier application number: M022
TopCare Cherry Flavor	PHENOL	TOPCO ASSOCIATES, LLC	5d3f0610-deb4-4180-ae19-2c65ed2f368b	2025-11-10	Warnings	Exact identifier application number: M022
Topcare Sore Throat Menthol Flavor	PHENOL	TOPCO ASSOCIATES LLC	fb1f2c11-2508-4985-bae5-7d547bd6aa23	2025-11-10	Warnings	Exact identifier application number: M022
Zilactin-B	BENZOCAINE	ASCENT CONSUMER PRODUCTS, INC	42eeb3d4-bac6-4e29-e063-6294a90a644d	2025-11-06	Warnings	Exact identifier application number: M022
Zilactin Early Relief Cold Sore	BENZYL ALCOHOL	ASCENT CONSUMER PRODUCTS, INC	42ef8bfa-c4d9-01cf-e063-6394a90ac88a	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	106b6115-d043-4050-80c6-1d82456dea02	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	4c278122-2643-46bf-9e44-11985210a16e	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fee9969d-ad1a-4f44-9741-a0a44c9e1128	2025-11-06	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	Target Corporation	0ddf9945-147d-4b25-98a6-4e9f12a4656f	2025-11-05	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	e6a312e5-17ac-46f0-8723-4e40eeecd69f	2025-11-04	Warnings	Exact identifier application number: M022
PEROXY SHIELD MOUTH SORE	1.5% HYDROGEN PEROXIDE	Dental Technologies, Inc.	a72e433b-1b7d-4a0c-e053-2995a90a30c4	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ae628766-25b7-4b4f-abb8-a43faf2f44b9	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	719743f9-21fc-4568-b879-acdfa4639464	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ff0695a1-1d7d-4b51-97fd-689e56d914fe	2025-11-04	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f7edf75c-cdba-4dde-bfc5-a04af34759d3	2025-11-03	Warnings	Exact identifier application number: M022
7 Select Oral Pain Maximum Strength Relief	BENZOCAINE	7-ELEVEN, INC.	f170a570-1c50-4b9a-be16-9b01bf5eaa74	2025-10-31	Warnings	Exact identifier application number: M022
Oral Pain Relief	BENZOCAINE AND BENZALKONIUM CHLORIDE	Universal Distribution Center LLC	18520f9b-4d35-1e9c-e063-6294a90aaa39	2025-10-30	Warnings	Exact identifier application number: M022
Iodent Oral Analgesic	BENZOCAINE	United Exchange Corp.	63902125-f8dc-0ada-e053-2991aa0a7ce5	2025-10-30	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	BETTER LIVING BRANDS, LLC	3bded237-4d2c-4b38-bedc-267fdc374194	2025-10-29	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	817c0dad-d109-428e-adb5-3354604acc94	3
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	817c0dad-d109-428e-adb5-3354604acc94	3
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	817c0dad-d109-428e-adb5-3354604acc94	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0135-0451-01	00135045101	500 mL in 1 BOTTLE (0135-0451-01)	500 ml	2024-01-02	No	No	Current