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
Ingredient	Strength
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
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4cd5d67d-43d8-f6d2-e063-6394a90a4070	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58228-7010-1	Burn Cream	10 in 1 BOX	CREAM	10	2
58228-7010-1	Burn Cream	0.9 g in 1 PACKET	CREAM	0.9	2
58228-7010-2	Burn Cream	0.9 g in 1 PACKET	CREAM	0.9	2
58228-7010-2	Burn Cream	2000 in 1 BAG	CREAM	2000	2

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 96 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DK12 Shower Gel Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e4ff0e-ef63-ef3b-e063-6294a90aa2b8	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Vitamin E Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe9270c0-bf6b-f0ff-e053-6394a90ae8f1	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2e51b-212b-368e-e063-6294a90a871c	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Fresh Energy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe80635d-9594-abf3-e053-6394a90aa78b	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Shower Gel Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e36111-ed4e-12de-e063-6294a90af639	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Creamy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe7fde7e-82fc-c13f-e053-6394a90aff68	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Oatmeal Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe16387b-1b16-1f41-e053-6294a90ae2c0	2024-12-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Isopropyl Alcohol Pad	ISOPROPYL ALCOHOL	Fourstar Group USA, Inc.	27edf5dc-3e68-bdd0-e063-6394a90ac485	2024-11-27	Warnings	Exact identifier application number: M003
MicroKlenz Antimicrobial	BENZETHONIUM CHLORIDE	Medline Industries, LP	115dda08-709c-490a-9693-419b51441960	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ALCOHOL PAD	Acme United Corporation	55421010-d806-4ca4-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Hydrogen Peroxide 3%	HYDROGEN PEROXIDE	Acme United Corporationn	f1db8929-9b95-0d6e-e053-2995a90a817f	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	d71047f6-1353-c758-e053-2995a90a962c	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ISOPROPYL ALCOHOL	Acme United Coporation	a01fec1b-1339-40b9-e053-2995a90aeda5	2024-11-23	Warnings	Exact identifier application number: M003
Med-Nap Sterile Alcohol Prep Pads	ISOPROPYL ALCOHOL	Acme United Corporation	c6eff57b-d537-69c8-e053-2a95a90adc3a	2024-11-23	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic	ISOPROPYL ALCOHOL	Acme United Corporation	a810e723-ad0c-8c71-e053-2995a90a0acc	2024-11-23	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0dcc9bd2-aea5-4c27-9956-47d56221726b	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	9a9d42ad-79d5-4acc-b5d9-cb7468961d47	2024-11-22	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	044a6287-f568-4cfa-a813-7fc0e6ffc352	2024-11-22	Warnings	Exact identifier application number: M003
NEXXGEN 70% RUBBING ALCOHOL	ISOPROPYL ALCOHOL	A & A Nexxgen LLC	ce73ac48-c5af-4a35-950c-62ff0232aa30	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8	2024-11-22	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	4cd5d67d-43d8-f6d2-e063-6394a90a4070	2
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	4cd5d67d-43d8-f6d2-e063-6394a90a4070	2
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	4cd5d67d-43d8-f6d2-e063-6394a90a4070	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58228-7010-1	58228701001	10 PACKET in 1 BOX (58228-7010-1) / .9 g in 1 PACKET	10 packet	2026-01-13	No	No	Current
58228-7010-2	58228701002	2000 PACKET in 1 BAG (58228-7010-2) / .9 g in 1 PACKET	2000 packet	2026-01-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ProStat First Aid Burn Cream	Prostat First Aid \| Trifecta Pharmaceuticals USA LLC	2026-03-31	HUMAN OTC DRUG LABEL	2