Home NDC 58228-7000 Burn Cream
Product NDC 58228-7000
11-digit product format 582287000
Labeler code 58228
Product ID 58228-7000_4f9ae17d-4d7d-f396-e063-6294a90a4037
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride, Lidocaine HCI
Dosage form CREAM
Route TOPICAL
Labeler Prostat First Aid
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-13
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength .0013; .005 g/g; g/g
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 Burn Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .0013 g/g LIDOCAINE HYDROCHLORIDE .005 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup 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 1012100 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 58228-7000-1 Burn Cream 0.9 g in 1 PACKET CREAM 0.9 1 58228-7000-1 Burn Cream 25 in 1 BOX CREAM 25 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 9 of 115 · 2,286 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 58228-7000-1 58228700001 25 PACKET in 1 BOX (58228-7000-1) / .9 g in 1 PACKET 25 packet 2026-01-13 No No Current