FDA.reportPublic FDA data

Burn Cream

Product NDC
58228-7010
11-digit product format
582287010
Labeler code
58228
Product ID
58228-7010_4e553aa3-41d4-1512-e063-6394a90ab870
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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012100Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4cd5d67d-43d8-f6d2-e063-6394a90a4070Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-7010-1Burn Cream10 in 1 BOXCREAM102
58228-7010-1Burn Cream0.9 g in 1 PACKETCREAM0.92
58228-7010-2Burn Cream0.9 g in 1 PACKETCREAM0.92
58228-7010-2Burn Cream2000 in 1 BAGCREAM20002

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 47 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.479beac0-16bc-a88c-e063-6394a90a42f52026-01-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Silicone Case 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.478b0ba2-d8ce-8101-e063-6294a90a64642026-01-03WarningsExact identifier
application number: M003
CASA COLADA SAPRY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47679265-2ec3-4c62-e063-6294a90a60b62026-01-02WarningsExact identifier
application number: M003
Fiji Punch Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4767ed4b-ebec-ca75-e063-6294a90a82d32026-01-02WarningsExact identifier
application number: M003
VILLA VANILLA HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47682ec1-5479-2ea5-e063-6394a90aa1922026-01-02WarningsExact identifier
application number: M003
Wipex Sanitizing WipesBENZALKONIUM CHLORIDEUnico476d7085-82d8-5e84-e063-6394a90a64482026-01-02WarningsExact identifier
application number: M003
Alcohol PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.74dc43d1-2aba-4f8a-876a-ce712ad37eeb2026-01-01WarningsExact identifier
application number: M003
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
application number: M003
Iodine Prep Pad AntisepticPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.0fdded64-4e89-d28c-e063-6394a90a7b8f2026-01-01WarningsExact identifier
application number: M003
OP First Aid Series Alcohol Prep PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4555-358e-e053-2995a90ae0ff2026-01-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAstera International LLCa5189240-19ce-7715-e053-2995a90ad0432025-12-31WarningsExact identifier
application number: M003
Water Jel Hydrogen PeroxideHYDROGEN PEROXIDEWater-Jel Technologiesf508c3cb-e162-4d11-9513-ff44918f82c02025-12-31WarningsExact identifier
application number: M003
HEB 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLHEB Grocery Companye8dd7f84-3690-4ab3-a21f-43bf66984f4b2025-12-30WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
application number: M003
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
application number: M003
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
application number: M003
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN4cd5d67d-43d8-f6d2-e063-6394a90a40702
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD4cd5d67d-43d8-f6d2-e063-6394a90a40702
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY4cd5d67d-43d8-f6d2-e063-6394a90a40702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-7010-15822870100110 PACKET in 1 BOX (58228-7010-1) / .9 g in 1 PACKET10 packet2026-01-13NoNoCurrent
58228-7010-2582287010022000 PACKET in 1 BAG (58228-7010-2) / .9 g in 1 PACKET2000 packet2026-01-13NoNoCurrent