Home NDC 58228-2012-1 PROSTAT FIRST AID Burn Ease, 0.9g
Product NDC 58228-2012
Requested package NDC 58228-2012-1
11-digit product format 582282012
Labeler code 58228
Product ID 58228-2012_401216de-924e-7a0a-e063-6394a90ac498
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 2025-09-30
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 58228-2012-1 PROSTAT FIRST AID Burn Ease, 0.9g 25 in 1 BOX GEL 25 1 58228-2012-1 PROSTAT FIRST AID Burn Ease, 0.9g 900 in 1 CARTON GEL 900 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 76 of 151 · 3,010 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 58228-2012-1 58228201201 900 BOX in 1 CARTON (58228-2012-1) / 25 PACKET in 1 BOX / .9 g in 1 PACKET 900 box 2025-09-30 No No Current