Home NDC 58228-7080 Burn Cream
Product NDC 58228-7080
11-digit product format 582287080
Labeler code 58228
Product ID 58228-7080_5dc00980-1217-3bbd-e063-6294a90a0a02
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
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 92 of 114 · 2,270 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL My Imports USA, LLC d4d77ec3-4930-74f0-e053-2a95a90a962a 2024-12-18 Warnings Exact identifier application number: M003 91% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7adaf-c0fd-82fa-e053-2995a90ab9f6 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA, LLC de47bf08-f64e-781d-e053-2a95a90ab08f 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d80ae4-3fba-4605-e053-2a95a90a2119 2024-12-18 Warnings Exact identifier application number: M003 American Red Cross 50% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC de47a879-9cd0-5fbb-e053-2a95a90a1fba 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5ee961-1d64-0d9d-e053-2a95a90a6010 2024-12-18 Warnings Exact identifier application number: M003 70% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL SZY Holdings, LLC dba EverReady First Aid 1e39b0f4-66d1-47ac-aed6-d6ac019888ce 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5eb0df-cd2d-691c-e053-2995a90a2511 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL First Aid Research Corp. 7d1c0382-31b3-48d0-a514-c5cc45a2299e 2024-12-18 Warnings Exact identifier application number: M003 First Aid Only First Aid-Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Acme United Corporation f31a44ff-e4ac-de1e-e053-2a95a90ab036 2024-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer (Lavender Rosemary) HAND SANITIZER SPRAY Tubby Todd 2992a52a-21a9-18be-e063-6294a90a834d 2024-12-18 Warnings Exact identifier application number: M003 CVS Decolorized Iodine ALCOHOL CVS Pharmacy d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd 2024-12-18 Warnings Exact identifier application number: M003 De La Cruz Decolorized Iodine ETHYL ALCOHOL DLC Laboratories, Inc. 5d8f6aaa-0b87-1166-e053-2991aa0a297f 2024-12-18 Warnings Exact identifier application number: M003 Humco Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 1e078022-f32c-48bd-8add-f83aebcc5812 2024-12-18 Warnings Exact identifier application number: M003 Univ of Vermont Medical Center Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7841cfa9-e94e-4c3d-b5fb-676924017845 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Mothers Vaginal ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7f1a85fd-086b-4fc7-abac-863dd3ea505a 2024-12-17 Warnings Exact identifier application number: M003 Mary Kay Satin Hands Shea Hand Sanitizer ALCOHOL Mary Kay Inc. b6c2b979-2940-1569-e053-2995a90a532c 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive Decolorized Iodine ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981529a-2bd0-3e9e-e063-6294a90a7236 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981cb97-17de-ebda-e063-6394a90ad281 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital H.E.A.R.T. Strings Tote ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc f8369a27-1995-4fdd-a282-35c344c11d83 2024-12-17 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58228-7080-1 58228708001 25 PACKET in 1 BOX (58228-7080-1) / .9 g in 1 PACKET 25 packet 2026-01-13 No No Current