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 11 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Humco Gentian Violet 2% GENTIAN VIOLET 2% Humco Holding Group, Inc. a07f61e5-0215-419a-a68a-1d814417c35f 2026-07-09 Warnings Exact identifier application number: M003 GNP Gentian Violet 1% GENTIAN VIOLET 1% Amerrisource Bergen 5d07274f-e848-6c60-e053-2991aa0a40d8 2026-07-09 Warnings Exact identifier application number: M003 Drs pharmacy triple antibiotic Pain plus itch plus Scar BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT OL PHARMA TECH, LLC 16273878-2f58-0d26-e063-6394a90a47d2 2026-07-09 Warnings Exact identifier application number: M003 Drs. Pharmacy Triple Antibiotic Plus Pain relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE OL PHARMA TECH, LLC Drs PHARMACY 1626fa89-cec0-6467-e063-6294a90aa2a4 2026-07-09 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 56148c12-7d6f-26bf-e063-6294a90a93df 2026-07-08 Warnings Exact identifier application number: M003 Povidone-Iodine POVIDONE-IODINE CARDINAL HEALTH 110, LLC. DBA LEADER 4f0d8da5-a75b-acc7-e063-6394a90ae839 2026-07-08 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical Mango ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 5600cf8a-5aba-1a22-e063-6394a90a8083 2026-07-07 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5600dc30-192d-19b1-e063-6394a90a66d3 2026-07-07 Warnings Exact identifier application number: M003 70% ISOPROPYL ALCOHOL Save-A-Lot Food Stores Ltd a592326c-c062-4ebf-b8dd-83f7e6f2f22b 2026-07-07 Warnings, Adverse reactions Exact identifier application number: M003 Amazon Basics Citrus Scent Antibacterial Hand Wipes BENZALKONIUM CHLORIDE Amazon.com Services LLC 52e5b1a4-3a84-c4cb-e063-6394a90a822c 2026-07-07 Warnings Exact identifier application number: M003 Amazon Basics Fresh Scent Antibacterial Hand Wipes BENZALKONIUM CHLORIDE Amazon.com Services LLC 5256f38a-74b6-0d18-e063-6294a90a5b46 2026-07-07 Warnings Exact identifier application number: M003 Hand Sanitizer ETHYL ALCOHOL EverywhereAire LLC b48f9e6b-c616-3607-e053-2995a90a37f5 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands hand sanitizer ETHYL ALCOHOL EverywhereAire LLC b6af3009-78c2-2312-e053-2995a90af90a 2026-07-06 Warnings Exact identifier application number: M003 Hand Sanitizer gel ALCOHOL EverywhereAire LLC d2a6c866-3f1e-20f1-e053-2995a90a26cc 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands HAND SANITIZER ETHANOL-BASED EverywhereAire LLC eab3ab67-cb27-6c2b-e053-2a95a90ace12 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands Sandalwood ETHANOL HAND SANITIZER EverywhereAire LLC 18612a10-8667-b0ef-e063-6394a90a208e 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands ETHANOL HAND SANITIZER EverywhereAire LLC b86824c2-4fae-d597-e053-2995a90ad1da 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands Lemon Olive Oil Hand Sanitizer ETHANOL HAND SANITIZER EverywhereAire LLC 42f8c2fb-a4e6-9416-e063-6294a90af9d5 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands HAND SANITIZER ETHANOL BASED EverywhereAire LLc eab52ae1-f588-b08b-e053-2995a90a96b2 2026-07-06 Warnings Exact identifier application number: M003 PlaneAire Hands hand sanitizer HAND SANITIZER ETHANOL-BASED EverywhereAire LLC eab19649-21fc-2fa4-e053-2995a90a90f9 2026-07-06 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