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 40 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Hydrogen Peroxide Wipes HYDROGEN PEROXIDE CVS Pharmacy d2c22ab0-9647-4025-8282-6b492209b04c 2026-01-20 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes ALCOHOL Germs Be Gone LLC 2bd6249b-f215-7aa9-e063-6394a90a6580 2026-01-20 Warnings Exact identifier application number: M003 SPA HAND SANITIZER SUMMER LEMON ETHYL ALCOHOL Rejoice International Corp. 48dd563a-0558-cc76-e063-6294a90ab041 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48de4a31-c620-6c1c-e063-6394a90abb96 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48df981a-74da-a629-e063-6294a90a7f40 2026-01-20 Warnings Exact identifier application number: M003 Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker Freeze ALCOHOL Scent Theory Products LLC 48c3d5e9-2d57-5a46-e063-6394a90a0722 2026-01-19 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487b648a-1680-6de5-e063-6394a90ab852 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487e6851-1ca3-f9db-e063-6394a90a56f1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. c3f0556d-f967-4f19-922c-57a2bf184892 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America 3b5b46d0-308a-4649-8384-246da3a18ba1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America bf69cc74-ebe9-40c3-a95a-a489492cc693 2026-01-16 Warnings Exact identifier application number: M003 NEXXGEN 50% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC d48232ab-ab55-488a-9cc1-77c8d0ba992e 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 486ee2e0-2222-0574-e063-6294a90a9eff 2026-01-15 Warnings Exact identifier application number: M003 Benzalkonium Chloride SANITIZING HAND WIPES ALO NEW YORK LLC d3afde78-b9f6-3648-e053-2a95a90a4024 2026-01-15 Warnings Exact identifier application number: M003 BIOPURE Hand Sanitizer Spray-Coastal Glow HAND SANITIZER SPRAY Quest USA Corp 48254577-9f1e-9389-e063-6394a90a92f1 2026-01-15 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487a4c8e-4fb3-6bff-e063-6294a90abd53 2026-01-15 Warnings Exact identifier application number: M003 Gold Bond Hydrating Hand Sanitizer ETHYL ALCOHOL Chattem, Inc. 96fe0191-0d34-4bf3-8f93-0e64764c353a 2026-01-14 Warnings Exact identifier application number: M003 Alcohol Prep Awabs ISOPROPYL ALCOHOL Enlightening Pallet Industry Co., Limited 26c7db1e-86a9-8765-e063-6294a90a634f 2026-01-14 Warnings Exact identifier application number: M003 Caring Hands HAND MOISTURIZING SANITIZER Gleeco Labs LLC 2ced5dc5-47dd-1b71-e063-6394a90a0e3d 2026-01-14 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL DealMed Medical Supplies LLC 04e6edb5-07ef-4ed4-ba68-ed183386b5ab 2026-01-13 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