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 6 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CharmTex Lightly Scented Antibacterial	BENZETHONIUM CHLORIDE	Yangzhou Jyr daily chemical Co., Ltd	4b642dfa-f044-4410-81e4-142f0497f0f3	2026-08-06	Warnings	Exact identifier application number: M003
antibacterial wipes 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	585dec39-ccb8-d2ba-e063-6394a90aec0f	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer PASSION MANGO SPLASH	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585df6ce-4625-d5d2-e063-6394a90a7fcb	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer LILY SPRINGS	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e0c24-7f5f-4ba7-e063-6294a90a7597	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer WATERMELON POP	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e3ced-fa45-8576-e063-6294a90af50f	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer ALOE BREEZE	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e647c-2904-2d3f-e063-6394a90a2b79	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer LAVENDER DREAM	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e8222-fad5-4409-e063-6394a90a9c60	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer JUICY APPLE	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585eb222-5495-65ed-e063-6394a90a7cfa	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer PEACH GLOW	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585ed56e-362e-7c50-e063-6394a90a1932	2026-08-06	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent ReadyInCase	ISOPROPYL ALCOHOL	P & L Development, LLC	57c496b3-10ab-4a72-8d8f-42a2256189dd	2026-08-06	Warnings	Exact identifier application number: M003
PROHEAL ALCOHOL PREP PADS	ISOPROPYL ALCOHOL	Click Industries LLC	d272c1f6-e9c9-4099-9d24-f5aae44082ae	2026-08-05	Warnings	Exact identifier application number: M003
Wish Sanitizing Hand Wipes	BENZALKONIUM CHLORIDE	Zhejiang Bright Care Co., Ltd.	c81c0924-bb01-4fa2-b933-8777358e45e7	2026-08-05	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOM	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5833c261-021a-2db2-e063-6394a90a22b0	2026-08-04	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Soft Petals	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	583438a6-c06c-87f5-e063-6394a90adec1	2026-08-04	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Hibiscus and Aloe	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5834801e-20e5-bffb-e063-6394a90a0359	2026-08-04	Warnings	Exact identifier application number: M003
Medi-First Antiseptic Wipes	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	d31fe110-6d75-bf15-e053-2a95a90a8694	2026-08-03	Warnings	Exact identifier application number: M003
First Shield	HYDROGEN PEROXIDE	EVER READY FIRST AID	94307d2f-5366-4fdb-b919-4a8658dda058	2026-08-03	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Passion Fruit Splash	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	583159a9-331a-b53b-e063-6294a90a41a3	2026-08-03	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Fresh Squeezed Spearmint	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	581b4b8d-fe65-f297-e063-6394a90a5a43	2026-08-02	Warnings	Exact identifier application number: M003
Mistify Hand Sanitizer Cotton Candy and Gummy Bear	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5987e492-b3b6-ed57-e063-6394a90a223a	2026-08-01	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