Home NDC 52000-437 0.5% LIDOCAINE BURN RELIEF
Product NDC 52000-437
11-digit product format 520000437
Labeler code 52000
Product ID 52000-437_7c908ad5-a800-4dc7-8d3c-19b2824fa484
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Universal Distribution Center LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-19
Substance LIDOCAINE HYDROCHLORIDE
Active strength .5 g/100g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 0.5% LIDOCAINE BURN RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE .5 g/100g
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 1011849 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 52000-437-08 0.5% LIDOCAINE BURN RELIEF 226 g in 1 BOTTLE, PLASTIC GEL 226 1 52000-437-08 0.5% LIDOCAINE BURN RELIEF 3 in 1 BOX GEL 3 1
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 Marketing start Sample Exclude flag Status 52000-437-08 52000043708 3 BOTTLE, PLASTIC in 1 BOX (52000-437-08) / 226 g in 1 BOTTLE, PLASTIC 2026-01-19 No No Current