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 99 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 0742f251-5fc9-c015-e063-6394a90a79b1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ETHYL ALCOHOL Whole Foods Market, Inc. 07436407-7a15-7cee-e063-6294a90a9651 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 07f7e966-e57e-dede-e063-6294a90acbf5 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. ec8c7597-a3f1-65a8-e053-2995a90a69a1 2024-11-02 Warnings Exact identifier application number: M003 Lemongrass Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25ca3908-24aa-5e4f-e063-6394a90a7a88 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Decolorized Iodine ETHYL ALCOHOL Sanvall Enterprises, Inc 16c92427-84d2-cad5-e063-6394a90af435 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Mercurochrome BENZALKONIUM CHLOLRIDE Sanvall Enterprises, Inc 16c6c2f0-0f08-e640-e063-6394a90aa01d 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Gentian Violet GENTIAN VIOLET Sanvall Enterprises, Inc 1922518d-e49b-5010-e063-6394a90a9112 2024-10-31 Warnings Exact identifier application number: M003 Lavender Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cada8c-8c80-c140-e063-6294a90a3336 2024-10-31 Warnings Exact identifier application number: M003 Peppermint Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cb382a-6e66-05e6-e063-6294a90a9165 2024-10-31 Warnings Exact identifier application number: M003 RITE AID Maximum strength pain relieving BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE RITE AID c87671cb-d736-4ec6-ab10-94dff54925b2 2024-10-30 Warnings Exact identifier application number: M003 H2OCEAN NOTHING BENZALKONIUM CL, LIDOCAINE HCL H2Ocean, LLC 77896ac3-960c-41ac-8b40-053f24526fe3 2024-10-23 Warnings Exact identifier application number: M003 Blue Green Foam BENZALKONIUM CHLORIDE H2Ocean, LLC 8627bf8b-2cce-45de-b37f-8478462645fa 2024-10-23 Warnings Exact identifier application number: M003 CVS HEALTH CONTINUOUS HAND SANITIZER ALCOHOL CVS PHARMACY c89a28ac-ab53-46dd-e053-2a95a90a3284 2024-10-22 Warnings Exact identifier application number: M003 TRADER JOES HAND SANITIZER LAVENDER ETHYL ALCOHOL Trader Joe's Company 4d782831-dab8-4553-9786-b5172813553e 2024-10-22 Warnings Exact identifier application number: M003 TRADER JOES HAND SANITIZER GRAPEFRUIT LEMON ALCOHOL Trader Joe's Company f4c1e80a-847b-4407-92b7-570c032bea60 2024-10-22 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 99% ISOPROPYL ALCOHOL Universal Distribution Center LLC 678a9b14-2838-4358-9673-fc23e0f58efb 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Universal Distribution Center LLC a9960d2f-f13a-4168-b2e9-d6f4a35d84ae 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL Universal Distribution Center LLC 5db1659e-3a13-47f0-90ae-f8f192c6111a 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% with Wintergreen ISOPROPYL ALCOHOL Universal Distribution Center LLC 3dcdc1cc-ece8-4b47-a236-ee57c375bb99 2024-10-21 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