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 48 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sanitizing Wipes BENZALKONIUM CHLORIDE Wipes LLC 9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3 2025-12-19 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. afeccd10-c7e5-6193-e053-2995a90a9a5a 2025-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. ae4311f8-fc40-38a7-e053-2a95a90ae829 2025-12-18 Warnings Exact identifier application number: M003 Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fc8cb10c-4973-c0bd-e053-6394a90a6fdb 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf27cbf-9535-1356-e053-6394a90a0362 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf30b3a-c25b-7aaf-e053-6394a90affda 2025-12-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ab5e8-029a-fe9d-e063-6294a90ac14d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ad5ba-253f-2a30-e063-6294a90a261d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462af072-6709-546f-e063-6294a90aacc8 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b1d38-c7fa-992f-e063-6294a90ab78f 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b2d3f-67b0-c393-e063-6294a90a208a 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b36d0-0a1f-bda8-e063-6294a90a5792 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b39e9-cf8e-3268-e063-6394a90a69c0 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462a1437-154c-0324-e063-6294a90a1266 2025-12-17 Warnings Exact identifier application number: M003 Alcohol Prep Pads ISOPROPYL ALCOHOL Family Dollar Stores, Inc. 15af30ec-f77d-2f5c-e063-6394a90a0580 2025-12-17 Warnings Exact identifier application number: M003 Signature Select Isopropyl Alcohol Wipes (40 count) ISOPROPYL ALCOHOL Better Living Brands LLC c9efcad4-f85c-4b10-9984-55549a4ff026 2025-12-17 Warnings Exact identifier application number: M003 finipil 4 men only BENZETHONIUM CHLORIDE Equibal, Inc. aba2e3e6-6047-416d-8ca3-44f1033671e3 2025-12-17 Warnings Exact identifier application number: M003 finipil pro/elec BENZETHONIUM CHLORIDE Equibal, Inc. f68aa5db-7a4e-410f-8159-3356d9407d31 2025-12-17 Warnings Exact identifier application number: M003 Made for Men BENZETHONIUM CHLORIDE Equibal, Inc. d12f748d-7dc5-4cd7-9718-ebb47171d58b 2025-12-17 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