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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Gel Oral Pain Relief	BENZOCAINE BENZALKONIUM CHLORIDE	Savvy Care and Cosmetics	05ede7e4-5a0a-c942-e063-6294a90a8a24	2024-12-19	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	SODIUM BICARBONATE	Lotus Brands, Inc.	4a95c8c1-db7c-4791-ac58-3eac216a0126	2024-12-18	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon	SODIUM BICARBONATE	Lotus Brands, Inc.	6703b29d-cdc9-4c74-91c0-fb0c98dd043e	2024-12-18	Warnings	Exact identifier application number: M022
Red Cross Oral Pain Relief	BENZOCAINE	The Mentholatum Company	cbd41429-f730-4577-9f06-ef1831cf62e1	2024-12-17	Warnings	Exact identifier application number: M022
Red Cross Canker Sore	BENZOCAINE	The Mentholatum Company	54cfff96-6665-4b36-a15d-10bf6cf3a1f9	2024-12-17	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	116956644	2981217f-f250-c090-e063-6294a90a85b0	2024-12-17	Warnings	Exact identifier application number: M022
Kank-A Mouth Pain	BENZOCAINE	Blistex Inc.	eebc03ba-f849-4e70-a653-834f383b6aa4	2024-12-17	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8282a4a6-b77c-75fc-e053-2991aa0ad4ac	2024-12-16	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	9452bff4-8c08-eff9-e053-2a95a90a67ed	2024-12-16	Warnings	Exact identifier application number: M022
PHENOL	PHENOL	CHAIN DRUG MARKETING ASSOCIATION INC.	2379e23a-72fe-4e94-9d7e-9b623c0db174	2024-12-13	Warnings	Exact identifier application number: M022
KANKA SoftBrush	BENZOCAINE AND ZINC CHLORIDE	Blistex Inc	093f3545-1d8e-48a3-a533-e9c3ae6d740b	2024-12-12	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	826eaef8-4457-3dc2-e053-2991aa0a528b	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8281700c-10f9-841c-e053-2991aa0a918f	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	82824416-80de-76bd-e053-2a91aa0ad8b5	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	e3da0e63-a891-72bd-e053-2a95a90a58bc	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories, Inc.	e3d924b5-0788-46d3-e053-2995a90a027b	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	fa433031-7376-0e5b-e053-6394a90a5f75	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	eedf13dc-a009-027a-e053-2995a90a8ec8	2024-12-11	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola USA Inc.	763e8234-60be-4b1f-9f78-01c574f35d0a	2024-12-10	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola USA Inc.	989f8509-cd28-48e7-9aa1-baddfbcac95a	2024-12-10	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