Home NDC 59088-350-03 Lidotral Five Percent
Product NDC 59088-350
Requested package NDC 59088-350-03
11-digit product format 590880350
Labeler code 59088
Product ID 59088-350_1a156ffe-1ec8-d2f9-e063-6394a90a3381
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SPRAY
Route TOPICAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-06-04
Substance LIDOCAINE HYDROCHLORIDE
Active strength 50 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Lidotral Five Percent
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1545290 Internal RxNorm lookup 2684036 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 59088-350-03 Lidotral Five Percent 30 mL in 1 BOTTLE, SPRAY SPRAY 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-350 LIDOTRAL FIVE PERCENT (LIDOCAINE HYDROCHLORIDE) SPRAY [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20240606_1a156ffe-1ec9-d2f9-e063-6394a90a3381.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59088-350-03 59088035003 30 mL in 1 BOTTLE, SPRAY (59088-350-03) 30 ml 2024-06-04 No No Current