FDA.reportPublic FDA data

First Aid Burn Cream

Product NDC
58228-6244
11-digit product format
582286244
Labeler code
58228
Product ID
58228-6244_4601a16d-08c5-4b60-e063-6294a90a0dde
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Burn Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Front Line Safety
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-26
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
13; 50 mg/10000mg; mg/10000mg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
First Aid Burn Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE50 mg/10000mg
BENZALKONIUM CHLORIDE13 mg/10000mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f4ce2c2-f306-d95f-e063-6394a90ae7b3Available 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
58228-6244-1First Aid Burn Cream25 in 1 BOXCREAM253
58228-6244-1First Aid Burn Cream1800 in 1 CASECREAM18003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-6244FIRST AID BURN CREAM CREAM [FRONT LINE SAFETY]2Current NDC, 2 package rows20241127_0f4ce2c2-f306-d95f-e063-6394a90ae7b3.zip

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 1 of 157 · 3,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
FREEZE EASEMENTHOL 4%Global America Group LLC16553eda-ec34-485a-a11c-f51260efd9fa2026-09-03WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-6244-1582286244011800 BOX in 1 CASE (58228-6244-1) / 25 PACKET in 1 BOX / 900 mg in 1 PACKET1800 box2024-01-26NoNoCurrent