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 58 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Cardinal Health	5459a0b4-65ca-455e-80b2-3fe1b24e0137	2025-10-23	Warnings	Exact identifier application number: M003
Hand Sanitizing Wipes	ETHYL ALCOHOL	Phoenix Healthcare Solutions LLC	c68d2d73-be78-8e1c-e053-2995a90a3a37	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	a7d77afc-588d-47d7-be2f-686ff3d75da2	2025-10-23	Warnings	Exact identifier application number: M003
Hand Sanitizing Wipes	ETHYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	ca9f8e68-cc15-42b4-81fd-e114e6a6d7df	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	50b24287-4c91-43d2-9c2e-42d3c086b3b3	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	51b707c6-df09-441b-a3d1-3f0c1b0886cc	2025-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep Swabstick	POVIDONE IODINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	8a0aba34-3f96-46b6-8521-f4388fb73edf	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	9c34be37-b6e2-4c08-96a5-d9bb0e738f2d	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Swab Sticks	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	91a9d6f7-d16c-46bf-8389-a6771e3ebfba	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	9d79480c-ceef-49f7-a830-171c2a262939	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Cardinal Health 200, Inc.	a1bccbf5-9cee-46c0-890c-02eb3577c193	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Wipes	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	04c2ac54-1f44-a5d2-e063-6394a90a99cc	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	2a160c89-c438-455d-910d-ac359d46786f	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	e917b371-3ca9-94f0-e053-2a95a90af8ad	2025-10-23	Warnings	Exact identifier application number: M003
Lemon Glycerine Swabsticks	GLYCERINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	436919f7-14cd-4318-9388-b3e1cbec176b	2025-10-23	Warnings	Exact identifier application number: M003
CareTouch Alcohol Prep Pad	ISOPROPYL ALCOHOL	Future Diagnostics Llc	91cfd7bf-9f42-49d5-b20d-281779d5272d	2025-10-23	Warnings	Exact identifier application number: M003
BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	PHOENIX HEALTHCARE SOLUTIONS, LLC	dab5e937-bd92-467b-b1ac-a2428a814bc3	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Wipe	ISOPROPYL ALCOHOL	Walmart Inc.	067c3983-d450-e86b-e063-6294a90ab758	2025-10-23	Warnings	Exact identifier application number: M003
CareTouch	ETHYL ALCOHOL	Future Diagnostics Llc	45f6a1da-f0ab-4783-a211-7fba5dc0530e	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	24337cc6-98fe-ca0b-e063-6394a90a8b7b	2025-10-23	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