Home NDC 58228-3867 PROSTAT FIRST AID Burn Ease, 0.9g
Product NDC 58228-3867
11-digit product format 582283867
Labeler code 58228
Product ID 58228-3867_40121303-0c77-78f5-e063-6294a90ade9a
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE
Dosage form GEL
Route TOPICAL
Labeler ProStat First Aid LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-17
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 PROSTAT FIRST AID Burn Ease, 0.9g
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 58228-3867-1 PROSTAT FIRST AID Burn Ease, 0.9g 1000 in 1 CARTON GEL 1000 1 58228-3867-1 PROSTAT FIRST AID Burn Ease, 0.9g 10 in 1 BOX GEL 10 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 Units Marketing start Sample Exclude flag Status 58228-3867-1 58228386701 1000 BOX in 1 CARTON (58228-3867-1) / 10 PACKET in 1 BOX / .9 g in 1 PACKET 1000 box 2025-09-17 No No Current