Home NDC 58228-6231 Burn Ease 3.5g
Product NDC 58228-6231
11-digit product format 582286231
Labeler code 58228
Product ID 58228-6231_46016210-ff8f-dbc7-e063-6294a90a3ab2
Type HUMAN OTC DRUG
Nonproprietary name Burn Ease 3.5g
Dosage form GEL
Route TOPICAL
Labeler Front Line Safety
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-26
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 3.5g
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 58228-6231-1 Burn Ease 3.5g 20 in 1 BOX GEL 20 3 58228-6231-1 Burn Ease 3.5g 480 in 1 CASE GEL 480 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58228-6231 BURN EASE 3.5G GEL [FRONT LINE SAFETY] 2 Current NDC, 2 package rows 20241127_0f52021f-af8a-5b95-e063-6294a90a2c2a.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 152 · 3,029 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 58228-6231-1 58228623101 480 BOX in 1 CASE (58228-6231-1) / 20 PACKET in 1 BOX / 3.5 g in 1 PACKET 480 box 2024-01-26 No No Current