FDA.reportPublic FDA data

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
IngredientStrength
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 95 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens 70% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreen Co.21f125a0-73e8-34a9-e063-6294a90a83962024-12-04WarningsExact identifier
application number: M003
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
application number: M003
Watermelon Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f0f9885-2ad5-09de-e063-6394a90ad0d72024-12-03WarningsExact identifier
application number: M003
Foster and Thrive Povidone-IodinePOVIDONE IODINEStrategic Sourcing Services, LLC28621f29-ce45-c6dc-e063-6294a90aa5f72024-12-03WarningsExact identifier
application number: M003
Sanitizing Hand Mist UnscentedETHYL ALCOHOLALO New York LLCe194daee-2197-4718-e053-2a95a90a48902024-12-03WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Global291eaa18-81f8-6907-e054-00144ff88e882024-12-03WarningsExact identifier
application number: M003
Aquabain Antibacterial Passion BerrysBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.aee5d7c2-93b3-f55e-e053-2995a90af72e2024-12-02WarningsExact identifier
application number: M003
Aquabain Antibacterial Fresh and RelaxBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d3086-7902-2837-e053-2995a90a39df2024-12-02WarningsExact identifier
application number: M003
Aquabain Antibacterial GrapefruitBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f49-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
application number: M003
Aquabain Antibacterial Red FruitsBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f4d-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand OatmealBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e1c5f6-195c-16d6-e063-6394a90abb862024-12-02WarningsExact identifier
application number: M003
Aquabain Instant Hand SanitizerETHYL ALCOHOL 70%Industria La Popular, S.A.b2e4d58d-adff-3cb2-e053-2995a90a392e2024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2289d-60f4-260c-e063-6394a90a96f62024-12-02WarningsExact identifier
application number: M003
Jabonito Kids Green Apple LiquidBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.021bc525-3ebe-efc2-e063-6394a90a3fe32024-12-02WarningsExact identifier
application number: M003
DK12 Shower Gel Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e4ff0e-ef63-ef3b-e063-6294a90aa2b82024-12-02WarningsExact identifier
application number: M003
DK12 Vitamin E Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe9270c0-bf6b-f0ff-e053-6394a90ae8f12024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2e51b-212b-368e-e063-6294a90a871c2024-12-02WarningsExact identifier
application number: M003
DK12 Fresh Energy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe80635d-9594-abf3-e053-6394a90aa78b2024-12-02WarningsExact identifier
application number: M003
DK12 Shower Gel CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e36111-ed4e-12de-e063-6294a90af6392024-12-02WarningsExact identifier
application number: M003
DK12 Creamy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe7fde7e-82fc-c13f-e053-6394a90aff682024-12-02WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-7080-15822870800125 PACKET in 1 BOX (58228-7080-1) / .9 g in 1 PACKET25 packet2026-01-13NoNoCurrent