Home NDC 59088-327-07 Lidotral 5 Percent Roll On Gel
Product NDC 59088-327
Requested package NDC 59088-327-07
11-digit product format 590880327
Labeler code 59088
Product ID 59088-327_1c4c9ce5-f12d-9c47-e063-6294a90a0b3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Puretek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-08-02
Substance LIDOCAINE HYDROCHLORIDE
Active strength 50 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 Additional Listing Data#
Finished product Yes
Brand name base Lidotral 5 Percent Roll On Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 50 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010057 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 59088-327-07 Lidotral 5 Percent Roll On Gel 85 g in 1 BOTTLE, WITH APPLICATOR GEL 85 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-327 LIDOTRAL 5 PERCENT ROLL ON GEL (LIDOCAINE HYDROCHLORIDE) GEL [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20240805_1c4c9ce5-f12d-9c47-e063-6294a90a0b3c.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 · 2 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 59088-327-07 59088032707 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) 85 g 2024-08-02 No No Current