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 7 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mistify Hand Sanitizer Soft Serve And Cherry Crush	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5987ed0c-2560-f787-e063-6394a90af7bd	2026-08-01	Warnings	Exact identifier application number: M003
Mistify Hand Sanitizer Coconut And Whipped Cream	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5988393d-1554-5588-e063-6394a90a470f	2026-08-01	Warnings	Exact identifier application number: M003
Strawberry Shortcake Raspberry Hand Sanitizer Wipes	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	598dcab0-ff1f-19ad-e063-6394a90ad684	2026-08-01	Warnings	Exact identifier application number: M003
Strawberry Shortcake Berry Twist Hand Sanitizer Wipes	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	598df8ff-6526-3d6d-e063-6394a90a056f	2026-08-01	Warnings	Exact identifier application number: M003
Strawberry Shortcake Strawberry Hand Sanitizer Wipes	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	598e08a1-3f78-47fe-e063-6394a90a645b	2026-08-01	Warnings	Exact identifier application number: M003
Sherk Hand Sanitizer Green Apple And Watermelon	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	598ec764-bad1-d14b-e063-6394a90a2305	2026-08-01	Warnings	Exact identifier application number: M003
Sherk Hand Sanitizer Blue Blueberry And Waffle Syrup	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	598f14fc-c34c-0b4e-e063-6394a90acf0c	2026-08-01	Warnings	Exact identifier application number: M003
Mistify Lavender Hand Sanitizer	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a0a6abf-fbab-3db5-e063-6294a90a6a30	2026-08-01	Warnings	Exact identifier application number: M003
Mistify Watermelon Hand Sanitizer	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a0ac249-7b91-a83f-e063-6294a90a9374	2026-08-01	Warnings	Exact identifier application number: M003
MISTIFY VANILLA SUGAR COOKIES HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a0b1e6c-850c-05e0-e063-6294a90afa46	2026-08-01	Warnings	Exact identifier application number: M003
MISTIFY SUGAR RUSH HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a0ba647-ee25-952a-e063-6294a90ad471	2026-08-01	Warnings	Exact identifier application number: M003
Mistify twin cherry hand sanitizer	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a148ff2-42bd-7288-e063-6394a90aae64	2026-08-01	Warnings	Exact identifier application number: M003
Mistify Hand Sanitizer Strawberry	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a170880-4867-9aac-e063-6394a90a3e4f	2026-08-01	Warnings	Exact identifier application number: M003
Mistify strawberry and cream hand sanitizer	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5a2b3f7b-5981-ed93-e063-6294a90a7b19	2026-08-01	Warnings	Exact identifier application number: M003
BIOPURE50CT ANTI BACTERIAL HAND WIPES	BIOPURE50CT ANTI BACTERIAL HAND WIPES	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd	57d3e290-1343-4075-e063-6394a90a41a6	2026-07-30	Warnings	Exact identifier application number: M003
Meridian Unwrapped antibacterial deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	c2d13d97-99ce-4a24-bdd6-684fbbf242a4	2026-07-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio Brulee	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57bd148e-f9eb-dfb6-e063-6394a90a1e12	2026-07-29	Warnings	Exact identifier application number: M003
Jelly Smack	BENZALKONIUM CHLORIDE	VULCAN MICROBIAL CORPORATION	eb79e11a-6c29-556b-e053-2a95a90a728a	2026-07-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber Melon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57cb54f7-07be-524f-e063-6294a90a2c94	2026-07-29	Warnings	Exact identifier application number: M003
Meridian wrapped antibacterial deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	de60d4d5-87bc-4400-94e2-8307a9bb0870	2026-07-29	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