Home NDC 58228-3832 Burn Ease
Product NDC 58228-3832
11-digit product format 582283832
Labeler code 58228
Product ID 58228-3832_46014976-cd58-9b35-e063-6294a90a24d3
Type HUMAN OTC DRUG
Nonproprietary name Burn Ease
Dosage form GEL
Route TOPICAL
Labeler ProStat First Aid LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-10
Substance LIDOCAINE HYDROCHLORIDE
Active strength 2 g/100g
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 Burn Ease
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 2 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 1011852 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 58228-3832-1 Burn Ease 6 in 1 BOX GEL 6 3 58228-3832-1 Burn Ease 3.5 g in 1 PACKET GEL 3.5 3 58228-3832-2 Burn Ease 600 in 1 CASE GEL 600 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58228-3832 BURN EASE GEL [PROSTAT FIRST AID LLC] 2 Current NDC, 3 package rows 20241127_f71eb4f5-2280-5867-e053-6394a90aac57.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 18 of 153 · 3,057 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 58228-3832-1 58228383201 6 in 1 BOX Historical 58228-3832-2 58228383202 600 BOX in 1 CASE (58228-3832-2) / 6 PACKET in 1 BOX (58228-3832-1) / 3.5 g in 1 PACKET 600 box 2023-04-10 No No Current