Home NDC 59088-307-07 Lidotral 3.88% Roll on
Product NDC 59088-307
Requested package NDC 59088-307-07
11-digit product format 590880307
Labeler code 59088
Product ID 59088-307_db1085fe-0a1e-c4cc-e053-2a95a90aa838
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine HCI
Dosage form GEL
Route TOPICAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-02-28
Substance LIDOCAINE HYDROCHLORIDE
Active strength 38.8 mg/g
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 3.88% Roll on
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 38.8 mg/g
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 2675768 Internal RxNorm lookup 2675772 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 59088-307-07 Lidotral 3.88% Roll on 85 g in 1 BOTTLE GEL 85 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-307 LIDOTRAL 3.88% ROLL ON (LIDOCAINE HCI) GEL [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20240301_db1085fe-0a1f-c4cc-e053-2a95a90aa838.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 59088-307-07 59088030707 85 g in 1 BOTTLE (59088-307-07) 85 g 2024-02-28 No No Current