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 73 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nufabrx Lower Leg Sleeve CAPSAICIN Nufabrx LLC b8e3e528-b7cd-e4b7-e053-2995a90a4029 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Ankle Sleeve CAPSAICIN Nufabrx LLC 013d60c7-a613-7cdf-e063-6294a90ad584 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Calf Sleeve CAPSAICIN Nufabrx LLC bd9459c4-5596-746f-e053-2995a90a5400 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Arm Sleeve CAPSAICIN Nufabrx LLC a7993eaf-6488-a818-e053-2995a90a7ea6 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Back Wrap CAPSAICIN Nufabrx LLC e4f85ac8-57cb-46eb-e053-2995a90a9b1c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Socks CAPSAICIN Nufabrx LLC 013cb66f-8695-b69f-e063-6294a90a699c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Neck Wrap CAPSAICIN Nufabrx LLC e10b420c-500d-5738-e053-2a95a90a008f 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Knee Sleeve CAPSAICIN Nufabrx LLC a5f455d4-5fc5-d516-e053-2a95a90a921e 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Socks CAPSAICIN Nufabrx LLC 00d7d5bf-ee03-e73d-e063-6394a90a5d94 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Elbow Sleeve CAPSAICIN Nufabrx LLC 27ef3ef0-2f98-6672-e063-6294a90aeca4 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Wrist Sleeve CAPSAICIN Nufabrx LLC 22572cf9-fc0c-d327-e063-6394a90a2186 2025-10-15 Warnings Exact identifier application number: M017 Antibacterial Lidocaine Wound Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE WALGREENS eff77965-dc7f-49af-e053-2995a90a1a97 2025-10-14 Warnings Exact identifier application number: M017 Pleasure Balm Kama Sutra BENZOCAINE Cosmetic Enterprises Ltd f370e3c4-65ca-4f3c-a5aa-70e198e681a2 2025-10-14 Warnings Exact identifier application number: M017 Vanicream HC Anti-Itch HYDROCORTISONE Pharmaceutical Specialties, Inc. 28b06507-27a5-2cb1-e054-00144ff8d46c 2025-10-14 Warnings Exact identifier application number: M017 Trilogel LIDOCAINE HYDROCHLORIDE Trifluent Pharma LLC 22af7d63-6a56-4a38-a95b-0f88410b23cb 2025-10-14 Warnings Exact identifier application number: M017 PROINNATE Numbing Cream MENTHOL Guangzhou Haishi Biological Technology Co., Ltd. 40c63645-8ed3-82b3-e063-6294a90a5267 2025-10-13 Warnings Exact identifier application number: M017 Cramergesic MENTHOL, METHYL SALICYLATE The Hygenic Company, LLC d0ffde7a-6942-74fc-e053-2a95a90a484a 2025-10-13 Warnings Exact identifier application number: M017 Tricylate MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Trifluent Pharma LLC 4869b63a-e01e-4a79-a493-7a1b4d3e914b 2025-10-13 Warnings Exact identifier application number: M017 Doloflex Pain Relief MENTHOL, METHYL SALICYLATE United Health & Beauty Corp 32a830cc-04d3-102e-e063-6294a90a1cad 2025-10-12 Warnings Exact identifier application number: M017 Lidocaine Pain Relieving Gel-Patch LIDOCAINE Nanjing Anxing Medical Technology Co., Ltd. 40c9b132-57ce-865e-e063-6394a90a2080 2025-10-10 Warnings Exact identifier application number: M017
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