Burn Cream

Product NDC: 55550-902
11-digit product format: 555500902
Labeler code: 55550
Product ID: 55550-902_cbe13d07-34ab-4156-a8cd-ab055385fc6d
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Total Resources International
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-14
Substance: BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength: 1.3; 5 mg/g; mg/g
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55550-902-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55550-902-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55550-902-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55550-902-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55550-902-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55550-902-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55550-902-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55550-902-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55550-902-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55550-902-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55550-902-21	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55550-902-21	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55550-902-21	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55550-902-21	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55550-902-21	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55550-902-21	`bd6a592717d7…`	`303034d00443…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 mg/g
LIDOCAINE HYDROCHLORIDE	5 mg/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
b971cc41-fe23-4be3-9564-e46d55df1d68	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55550-902-21	2025-04-21	C162847	48780-1	d6a99b39-37ca-a426-e053-dadaa90af4c2	Drug Facts
55550-902-21	2022-01-28	C162847	48780-1	d6a99b39-37ca-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55550-902-21	Burn Cream	0.9 g in 1 POUCH	CREAM	0.9		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55550-902	BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [TOTAL RESOURCES INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20250507_b971cc41-fe23-4be3-9564-e46d55df1d68.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 60 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Luxury Hand Sanitizer Cashmere Char	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41938c11-391c-0a55-e063-6394a90ad451	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Tea and Timber	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4193d08a-bc54-ef3b-e063-6294a90a0608	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41940273-689d-0f44-e063-6294a90a957f	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Vanilla Verdant	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41942841-faa9-114e-e063-6294a90a0e58	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Zen and Zest	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	419441a8-a6df-e15d-e063-6294a90a02ae	2025-10-20	Warnings	Exact identifier application number: M003
CVS Alcohol Prep	ISOPROPYL ALCOHOL	CVS Pharmacy	7abc66f2-faf6-421c-9c3c-b69f5a587246	2025-10-20	Warnings	Exact identifier application number: M003
Gentian Violet	GENTIAN VIOLET	World Perfumes Inc	419cc9a2-bfde-a516-e063-6294a90a065c	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender Drift	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a2d051-4920-76ee-e063-6294a90a5d3c	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach Nectar	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a36bb3-a648-3b5b-e063-6394a90aa4df	2025-10-20	Warnings	Exact identifier application number: M003
PROHEAL ALCOHOL XXL PREP PADS	ISOPROPYL ALCOHOL	Click Industries LLC	ec81be59-94a5-4675-9047-e3e82d7ad761	2025-10-20	Warnings	Exact identifier application number: M003
ALCOHOL PREP PAD	ISOPROPYL ALCOHOL	Guangdong Comfort Medical Products Co., Ltd.	3a2dea43-8123-3fb7-e063-6294a90a5e50	2025-10-19	Warnings	Exact identifier application number: M003
ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	3a40a31d-4032-71ba-e063-6294a90a48dc	2025-10-19	Warnings	Exact identifier application number: M003
ANTIBACTERIAL BANDAGES	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	6e43b8b3-2d49-8f76-e053-2a91aa0affb0	2025-10-19	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft Berry	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	418fed84-d4ab-7352-e063-6294a90a6dab	2025-10-19	Warnings	Exact identifier application number: M003
BZK CLEANSER	BENZALKONIUM CHLORIDE	Geri-Gentle Corporation	415eb5fb-5f88-d2dd-e063-6394a90abe5d	2025-10-17	Warnings	Exact identifier application number: M003
Medline Alcohol Prep Sterile, Large	ISOPROPYL ALCOHOL	Medline Industries, LP	c9fae7b6-2f4b-490b-9b17-a7297e738069	2025-10-16	Warnings	Exact identifier application number: M003
Medline Alcohol Prep Sterile, Medium	ISOPROPYL ALCOHOL	Medline Industries, LP	9a8584e1-b422-4b77-8464-4e022d578fad	2025-10-16	Warnings	Exact identifier application number: M003
Signature Select Pain Relieving	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	Safeway/Albartsons	3cab1b0c-4ffd-9c01-e063-6294a90ad15d	2025-10-16	Warnings	Exact identifier application number: M003
Medline Alcohol Prep	ISOPROPYL ALCOHOL	Medline Industries, LP	b43c0bff-82f8-c18d-e053-2995a90a8716	2025-10-16	Warnings	Exact identifier application number: M003
Medline	BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE	Medline Industries, LP	b1059e68-b240-056c-e053-2995a90a61b2	2025-10-16	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	b971cc41-fe23-4be3-9564-e46d55df1d68	3
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	b971cc41-fe23-4be3-9564-e46d55df1d68	3
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	b971cc41-fe23-4be3-9564-e46d55df1d68	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55550-902-21	55550090221	.9 g in 1 POUCH (55550-902-21)	2020-01-14	0000-00-00	No	No	Current