Salonpas LIDOCAINE PLUS

Product NDC: 55328-901
11-digit product format: 553280901
Labeler code: 55328
Product ID: 55328-901_cd6de492-966e-4127-aca7-dc865243b42a
Type: HUMAN OTC DRUG
Nonproprietary name: Benzyl alcohol, Lidocaine hydrochloride
Dosage form: LIQUID
Route: PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler: Hisamitsu America, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-09-01
Substance: BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE
Active strength: 10; 4 g/100g; g/100g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Pediculicide [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Salonpas LIDOCAINE PLUS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZYL ALCOHOL	10 g/100g
LIDOCAINE HYDROCHLORIDE	4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LKG8494WBH	Internal UNII lookup
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1943537	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
ea5b4a7f-d47d-4dbd-9288-c01329e387e5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55328-901-03	Salonpas LIDOCAINE PLUS	80 g in 1 TUBE	LIQUID	80		4
55328-901-03	Salonpas LIDOCAINE PLUS	1 in 1 BOX	LIQUID	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55328-901-03	ML - Milliliter	55328-901	45b99e7c-9b83-422c-9b06-a90589df4a24	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55328-901	SALONPAS LIDOCAINE PLUS (BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [HISAMITSU AMERICA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20241205_ea5b4a7f-d47d-4dbd-9288-c01329e387e5.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 139 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Bandage	LIDOCAINE	WellSpring Pharmaceutical Corporation	465dc46e-6435-4569-9516-f648d0fe0f09	2023-12-21	Warnings	Exact identifier application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	LABORATORIOS QUANTIUM LLC	c4efa317-8dd1-49e1-b7ca-9df2147edd3e	2023-12-21	Warnings	Exact identifier application number: M017
DDM Camphor Spirit	CAMPHOR 10%	Discount Drug Mart	5d56cbe6-4e48-79eb-e053-2a91aa0a74d3	2023-12-20	Warnings	Exact identifier application number: M017
Quality Choice Camphor Spirit	CAMPHOR 10%	Chain Drug Market Association	8d352a67-2024-43d0-b525-038d398949e6	2023-12-20	Warnings	Exact identifier application number: M017
Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Chain Drug Market Association	2cd60df3-bfde-4747-ba4f-7121612f2e63	2023-12-20	Warnings	Exact identifier application number: M017
Poison Ivy Wash	PRAMOXINE HCL	Chain Drug Market Association	873a546b-90ae-50cb-e053-2a91aa0adbfb	2023-12-20	Warnings	Exact identifier application number: M017
Premier Value Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharmacy Value Alliance LLC	9d63f8ed-fc50-0d84-e053-2a95a90a6e92	2023-12-20	Warnings	Exact identifier application number: M017
Ear Drops	CARBAMIDE PEROXIDE 6.5%	CVS Pharmacy	8a872991-01af-5fd0-e053-2995a90ac7f4	2023-12-20	Warnings	Exact identifier application number: M017
CVS Cold and Hot Roll-On	COOL AND HEAT PAIN RELIEF	CVS Pharmacy	b8cc578a-be6d-90c0-e053-2995a90a7742	2023-12-20	Warnings	Exact identifier application number: M017
Sunmark Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services LLC	667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa	2023-12-19	Warnings	Exact identifier application number: M017
DDM Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Discount Drug Mart	5d56c74f-604d-4fed-e053-2a91aa0a417c	2023-12-19	Warnings	Exact identifier application number: M017
HEB Camphor Phenol	CAMPHOR 10.8% AND PHENOL 4.7%	H E B	5d573883-001d-e5a4-e053-2991aa0a6203	2023-12-18	Warnings	Exact identifier application number: M017
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Exact identifier application number: M017
DermaWound Wound Care Venous Stasis	BENZOCAINE HYDROCHLORIDE	Progressive Doctors, LLC	6221ba86-8b7f-48c8-8284-6950f9fc36b1	2023-12-15	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	Humco Holding Group, Inc.	a8be9e46-1616-40a9-e053-2a95a90ac3bc	2023-12-15	Warnings	Exact identifier application number: M017
Hot/Cold Menthol 16% Roll-On	HOT/COLD MENTHOL 16% ROLL-ON	Humco Holding Group, Inc	a8bf9744-9979-13c1-e053-2a95a90a30aa	2023-12-15	Warnings	Exact identifier application number: M017
Freds Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Discount Drug Mart	8697b932-da5a-717e-e053-2a91aa0afcae	2023-12-12	Warnings	Exact identifier application number: M017
CVS Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	CVS	86972218-31fe-6942-e053-2991aa0a8850	2023-12-12	Warnings	Exact identifier application number: M017
Best Choice Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	value merchandisers	869631f8-aa1e-8ea4-e053-2a91aa0a5c57	2023-12-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Weeks & Leo Co., Inc.	0c5325e3-4796-856c-e063-6394a90a1f90	2023-12-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LKG8494WBH	BENZYL ALCOHOL	100-51-6	BENZYL ALCOHOL
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1943537	benzyl alcohol 10 % / lidocaine HCl 4 % Topical Solution	PSN	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	4
1943537	benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical Solution	SCD	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	4
1943537	benzyl alcohol 10 % / lidocaine HCl 4 % Topical Solution	SY	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55328-901-03	55328090103	1 TUBE in 1 BOX (55328-901-03) / 80 g in 1 TUBE	1 tube	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salonpas LIDOCAINE PLUS - Hisamitsu America, Inc.	Hisamitsu America, Inc.	2024-12-03	HUMAN OTC DRUG LABEL	4