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 79 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
The Pharma-C Company 3 Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	Kleen Test Products Corporation	7d1c94b1-66bd-4f22-beec-4975efd6b816	2025-04-30	Warnings	Exact identifier application number: M003
POVIDONE-IODINE PREP PADS MEDIUM	POVIDONE-IODINE PREP PADS MEDIUM	HF Acquisition Co. LLC, DBA HealthFirst	33f08f03-93fb-214d-e063-6394a90a73bd	2025-04-29	Warnings	Exact identifier application number: M003
SANSPRAY	ANTIBACTERIAL SANITIZER SPRAY	Beacon Promotions Inc	0e243179-37f6-45dc-e063-6394a90a5f80	2025-04-28	Warnings	Exact identifier application number: M003
Sanell Hand Sanitizer	ALCOHOL	OraLabs	0a6cc2a8-f568-45ae-8d82-a70103c774c7	2025-04-28	Warnings	Exact identifier application number: M003
Sanell Hand Sanitizer	ALCOHOL	OraLabs	7184b9ad-0125-413d-b054-f46239b8ca92	2025-04-28	Warnings	Exact identifier application number: M003
Pink Pineapple SCENTED HAND SANITIZER	ALCOHOL	MELON BIO-TECH (THAILAND) CO., LTD.	73543eed-e022-4d51-b606-000dcc023298	2025-04-28	Warnings	Exact identifier application number: M003
Vanilla Sugar SCENTED HAND SANITIZER	ALCOHOL	MELON BIO-TECH (THAILAND) CO., LTD.	6c790c49-7b4a-4e07-b5ce-9a31db84e01f	2025-04-28	Warnings	Exact identifier application number: M003
Strawberry Pound Cake SCENTED HAND SANITIZER	ALCOHOL	MELON BIO-TECH (THAILAND) CO., LTD.	34750790-4eec-4a2d-9686-2c69c1db79e6	2025-04-28	Warnings	Exact identifier application number: M003
Sweet Coconut SCENTED HAND SANITIZER	ALCOHOL	MELON BIO-TECH (THAILAND) CO., LTD.	f9062bbc-8534-4dcc-920a-19f13d1c0def	2025-04-28	Warnings	Exact identifier application number: M003
Germ Attack 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Natural Essentials, Inc.	3375d44e-5af6-8c7f-e063-6394a90abb4b	2025-04-25	Warnings	Exact identifier application number: M003
Germ Attack 91% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Natural Essentials, Inc.	3375e0d7-07fa-6489-e063-6294a90a91ec	2025-04-25	Warnings	Exact identifier application number: M003
Clear Defense	HAND SANITIZING WIPES	Melaleuca, Inc.	30dec472-8112-37d6-e063-6294a90a1f25	2025-04-24	Warnings	Exact identifier application number: M003
Quality Choice Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Chain Drug Marketing Association, Inc.	3347184c-ae72-bec2-e063-6294a90a2d05	2025-04-23	Warnings	Exact identifier application number: M003
Dukal Sterile Alcohol Prep Pad	ISOPROPYL ALCOHOL	Dukal LLC	00b2c444-8601-4d8f-b6bb-91b864fd9041	2025-04-23	Warnings	Exact identifier application number: M003
PREVENT HAND SANITIZER	ALCOHOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	ee2c3dd2-a82f-4bbf-a288-f0365b9893db	2025-04-23	Warnings	Exact identifier application number: M003
SANIFOAM HAND SANITIZER	ALCOHOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	e1cfa8ff-92e0-4931-98c9-287c8dcd5a99	2025-04-23	Warnings	Exact identifier application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	18720bd0-6ea8-2d1b-e063-6394a90abe2d	2025-04-23	Warnings	Exact identifier application number: M003
E-2 HAND ITEM 1095	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	18728ebb-c416-5efe-e063-6294a90abd91	2025-04-23	Warnings	Exact identifier application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	1871b1db-f881-e7fd-e063-6294a90ada98	2025-04-23	Warnings	Exact identifier application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	1870b08e-e5c3-7888-e063-6394a90a1c82	2025-04-23	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