Home NDC 85477-730-07 LidexaGel 5%
Product NDC 85477-730
Requested package NDC 85477-730-07
11-digit product format 854770730
Labeler code 85477
Product ID 85477-730_3899614e-a1ed-4642-937b-5d8e55a81c9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine HCl
Dosage form GEL
Route TOPICAL
Labeler Oncora Pharma, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-07-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 50 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC]; Amides [CS]; Antiarrhythmic [EPC]; Local Anesthesia [PE]
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base LidexaGel 5%
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 85477-730-07 85477073007 85 g in 1 TUBE (85477-730-07) 85 g 2026-07-01 0 Current