Home NDC 55328-901 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.
DailyMed Product Concepts# 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 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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# 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