Home NDC 55550-902 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 61 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Hand Sanitizer Lakeshore Fresh ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 41533b69-05e7-d5f7-e063-6294a90a2d2b 2025-10-16 Warnings Exact identifier application number: M003 Meijer Hand Sanitizer Pine Forest ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4153ac2a-e51c-f167-e063-6394a90a80d8 2025-10-16 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 412e961a-b7d4-b1c2-e063-6294a90a6b85 2025-10-15 Warnings Exact identifier application number: M003 equate First Aid Antiseptic POVIDONE-IODINE Walmart Inc. 43bbedec-be30-482a-8552-949b13d4bea1 2025-10-14 Warnings Exact identifier application number: M003 Tridergel BENZALKONIUM CHLORIDE Trifluent Pharma LLC f12d9e8c-1d69-49d9-a9e9-a392c681aa6c 2025-10-13 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe BENZOCAINE, ALCOHOL Total Resources International, Inc 5415073f-aa1d-4ed3-aa30-7470cd2efed1 2025-10-10 Warnings Exact identifier application number: M003 Lemyn Organics Medical-Grade Hand Sanitizer ALCOHOL Lemyn LLC b106289d-346a-74df-e053-2995a90aa426 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial Body Wash BENZALKONIUM CHLORIDE Spa de Soleil ab9dde33-1bd2-062f-e053-2a95a90a4d18 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial BENZALKONIUM CHLORIDE Spa de Soleil af89675e-e66f-0922-e053-2995a90ab9d2 2025-10-10 Warnings Exact identifier application number: M003 ANTISEPTIC WIPE 01 BENZALKONIUM CHLORIDE Total Resources International Inc. cf4a6a97-529e-7f11-e053-2a95a90a75a9 2025-10-10 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe ALCOHOL, LIDOCAINE HYDROCHLORIDE Total Resources International, Inc fff6f057-739e-40f1-8427-e1364c65af05 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Zhejiang Hudson Import& Export Co., Ltd 40b6c96c-e36f-6588-e063-6394a90adb46 2025-10-09 Warnings Exact identifier application number: M003 Curad ISOPROPYL ALCOHOL Medline Industries, LP c42de981-4e3f-1ac9-e053-2995a90aea98 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Avaria Health & Beauty Corp a3d87ef6-752b-b54b-e053-2a95a90af963 2025-10-08 Warnings Exact identifier application number: M003 Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic IODINE 2% Germa Products, LLC bf54254f-2ef3-102e-e053-2995a90ac083 2025-10-08 Warnings Exact identifier application number: M003 MediChoice BZK Antiseptic BENZALKONIUM CHLORIDE O&M HALYARD, INC. 82a7710d-a9fa-4f68-8322-046a765ae929 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. 79d41cf0-301f-44d4-a76c-f4850c7ddce9 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL O&M HALYARD, INC. 8b84c8ed-040e-4c07-94cb-d5bdda744648 2025-10-08 Warnings Exact identifier application number: M003 MediChoice of Hydrogen Peroxide 3 10 Volume HYDROGEN PEROXIDE O&M HALYARD, INC. 34e77ef4-297d-4362-8f6e-abf80158b7f0 2025-10-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE O&M HALYARD, INC. 0ad5990a-a18d-4753-826b-6da313926698 2025-10-08 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# 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