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 95 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 OZ BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. b621b4cd-20db-44d8-b114-a977deea8eb4 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 0.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. c3a053ba-65fe-4540-9c81-29700cda5efa 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3 OZ BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 2989afeb-8451-4a72-8456-195cd5117a41 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 1.25 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 17092ebf-8e57-4e1a-9bba-87a662c361c0 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 3ed3332e-f888-4b9c-aab7-99f8719b835e 2024-12-05 Warnings Exact identifier application number: M003 OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZER ETHYL ALCOHOL Archer Manufacturing, Inc. d05fbe85-26de-0d24-e053-2a95a90ab5cb 2024-12-05 Warnings Exact identifier application number: M003 OPS AB ANTIBACTERIAL FOAMING BENZALKONIUM CHLORIDE Archer Manufacturing, Inc. 615921dd-46e5-403c-9ed3-f30beb0c0bb9 2024-12-05 Warnings Exact identifier application number: M003 BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZER ETHYL ALCOHOL Archer Manufacturing, Inc. d334b7f0-01dc-7f59-e053-2a95a90a06b5 2024-12-05 Warnings Exact identifier application number: M003 BLACK OPS INSTANT HAND SANITIZER BENZALKONIUM CHLORIDE Archer Manufacturing, Inc. d3366750-18b8-1194-e053-2995a90a4359 2024-12-05 Warnings Exact identifier application number: M003 OPS RANCH HAND ANTIBACTERIAL FOAMING CHLOROXYLENOL Archer Manufacturing, Inc. d8187090-8423-062e-e053-2a95a90aad18 2024-12-05 Warnings Exact identifier application number: M003 BLACK OPS AB ANTIBACTERIAL FOAMING BENZALKONIUM CHLORIDE Archer Manufacturing, Inc. d335bf6d-dc75-bd80-e053-2a95a90abb56 2024-12-05 Warnings Exact identifier application number: M003 OPS INSTANT HAND SANITIZER BENZALKONIUM CHLORIDE Archer Manufacturing, Inc. d4c65a93-832a-6a8b-e053-2a95a90a77b8 2024-12-05 Warnings Exact identifier application number: M003 alcohol pad 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 03a6e8d4-535d-b316-e063-6294a90aebf5 2024-12-04 Warnings Exact identifier application number: M003 antiseptic towelette 01 BENZALKONIUM CHLORIDE Cosmuses Cosmetics (Ningbo) Co., Ltd. e9f2a1f1-ceb6-2f20-e053-2a95a90a18db 2024-12-04 Warnings Exact identifier application number: M003 BobBarker antibacterial wrapped body BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa5 2024-12-04 Warnings Exact identifier application number: M003 Walgreens 70% Isopropyl Alcohol ISOPROPYL ALCOHOL Walgreen Co. 21f125a0-73e8-34a9-e063-6294a90a8396 2024-12-04 Warnings Exact identifier application number: M003 Emory Johns Creek Amenity ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global 952ccb85-71bb-4d5d-ac9b-62851a39d36d 2024-12-04 Warnings Exact identifier application number: M003 Watermelon Hand Sanitizer Spray. 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1f0f9885-2ad5-09de-e063-6394a90ad0d7 2024-12-03 Warnings Exact identifier application number: M003 Foster and Thrive Povidone-Iodine POVIDONE IODINE Strategic Sourcing Services, LLC 28621f29-ce45-c6dc-e063-6294a90aa5f7 2024-12-03 Warnings Exact identifier application number: M003 Sanitizing Hand Mist Unscented ETHYL ALCOHOL ALO New York LLC e194daee-2197-4718-e053-2a95a90a4890 2024-12-03 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