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 11 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	56b8d0cc-2f35-7d38-e063-6294a90ad06d	2026-07-16	Warnings	Exact identifier application number: M017
ANTIPHLAMINE	L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE	Masaem Company	56b93c89-295b-f33a-e063-6294a90a5fe4	2026-07-16	Warnings	Exact identifier application number: M017
Meriwether Skin Pain Relief	MENTHOL, UNSPECIFIED FORM	Meriwether Skin LLC	f6e155be-5879-4176-bb0e-e364f2e5cdf9	2026-07-16	Warnings	Exact identifier application number: M017
Medi-First Muscle Rub Cream	MENTHOL, METHYL SALICYLATE	Unifirst First Aid Corporation	56a6b8b2-7ab0-9854-e063-6294a90ab5ba	2026-07-15	Warnings	Exact identifier application number: M017
Painsil Pain Relief Roll-On	LIDOCAINE HYDROCHLORIDE	Painsil LLC	dee39dff-5749-4ef2-a9ed-182f25e01f67	2026-07-14	Warnings	Exact identifier application number: M017
VARICOSE VEINS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL & LLC	5692914f-1b14-e3e3-e063-6394a90a94bf	2026-07-14	Warnings	Exact identifier application number: M017
ZyloRelief	LIDOCAINE HYDROCHLORIDE	Highmark Pharma LLC	635f5b98-f74c-495f-a537-686fcba9ccad	2026-07-14	Warnings	Exact identifier application number: M017
ENOKON PAIN RELIEF Spray.	PAIN RELIEF SPRAY.	Henan Enokon Medical Instrument Co., Ltd.	5675ec21-b947-2206-e063-6294a90aa509	2026-07-12	Warnings	Exact identifier application number: M017
Topcare Pain Relief Patch	PAIN RELIEF PATCH MEDICATED 5% MENTHOL	76162	4f00d0b8-d2f4-843b-e063-6294a90a332b	2026-07-12	Warnings	Exact identifier application number: M017
Penetral Roll-on	CAPSAICIN 0.025%	PureTek Corporation	56204c03-8b15-a8b5-e063-6394a90a8189	2026-07-10	Warnings	Exact identifier application number: M017
Intensive Healing Itch Relief	ITCH RELIEF CREAM	NeilMed Pharmaceuticals Inc	563ef1d5-2180-bc45-e063-6294a90a813d	2026-07-10	Warnings	Exact identifier application number: M017
AVON Foot Works Arthritis Achy Foot and Muscle	METHYL SALICYLATE	COSMAX USA, CORPORATION	56440d3f-bc93-cebb-e063-6294a90a5f79	2026-07-10	Warnings	Exact identifier application number: M017
CHEONG KUN PAIN RELIEVING	CAMPHOR	CHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED	557d5cb3-2a05-4f45-e063-6394a90a9b12	2026-07-10	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL	Reckitt Benckiser LLC	485c8208-c93b-5b84-e063-6394a90ab77a	2026-07-10	Warnings	Exact identifier application number: M017
Fit Mist Pain Relief	MENTHOL	Aroma Sensations Inc	f5a98544-8bd7-42dc-a594-5559e3920e29	2026-07-09	Warnings	Exact identifier application number: M017
Nuturna Sciatica	MENTHOL	Micelle Laboratories, Incorporated	ff200864-bedf-4138-bdec-2b23701406dd	2026-07-09	Warnings	Exact identifier application number: M017
Lidocaine cream	DRS LIDOCAINE 5% CREAM	OL PHARMA TECH LLC. (Drs. Pharmacy)	372fe018-1e5a-9ec4-e063-6294a90a1500	2026-07-09	Warnings	Exact identifier application number: M017
Nupharmisto 4% Lidocaine Numbing cream	LIDOCAINE 4%	EveryMarket Inc	5615e49d-e03b-f915-e063-6294a90a1786	2026-07-08	Warnings	Exact identifier application number: M017
CAREALL Musle and Joint	MENTHOL	New World Imports, Inc	561cc103-ae88-8f30-e063-6294a90a05c4	2026-07-08	Warnings	Exact identifier application number: M017
HealthWise Medicated Cold Hot	MENTHOL	Veridian Healthcare, LLC	561e1409-d1d8-e35d-e063-6394a90a4d8f	2026-07-08	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