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 103 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermal Wound Cleanser BENZETHONIUM CHLORIDE Smith & Nephew Medical Ltd. 18704cd5-1ecf-4e8c-9897-7e45394e68c8 2024-07-15 Warnings Exact identifier application number: M003 Novex Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 7832a0be-a8ce-4b56-a9bb-a375b97df287 2024-07-10 Warnings Exact identifier application number: M003 Callington Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 00ca48ca-893d-4a3f-ad90-119522664e08 2024-07-10 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Grape 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1c9095ad-ce19-3666-e063-6394a90ae22d 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb78ed-36f9-a7d2-e063-6394a90a6477 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb9671-1970-39f9-e063-6294a90ac079 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbc68e-2b6b-768c-e063-6294a90a643b 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbbc55-3f7d-76d1-e063-6294a90a5590 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb701f7-61c8-e5f4-e063-6294a90a0c3c 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb77267-73ad-efd2-e063-6294a90a43f7 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb7d6ca-ef7e-5225-e063-6294a90aa692 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc8a756-852f-6cf8-e063-6394a90a57e6 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Vanilla 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc90b2f-450f-1deb-e063-6394a90a6480 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb4316d-c8c6-3fa2-e063-6394a90a23d2 2024-07-07 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd f531053d-82e4-7613-e053-2995a90a349f 2024-07-02 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd 1ae5c268-1834-4ac2-931e-bb7fd0088cd2 2024-07-02 Warnings Exact identifier application number: M003 Quality Choice ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc 1262c5d7-63ef-f1c1-e063-6294a90a1f0f 2024-07-02 Warnings Exact identifier application number: M003 Genuine First Aid Antiseptic Towelette BENZALKONIUM CHLORIDE GFA Production (Xiamen) Co., Ltd. dfff78d2-e23c-40b2-8a49-8f4140bb0df6 2024-06-25 Warnings Exact identifier application number: M003 Walgreens 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Walgreen Company 03c497cc-c8b1-43b7-86ba-f9f9fc7432bf 2024-06-18 Warnings Exact identifier application number: M003 Antimicrobial BODY CLEANSER McKesson 8ff06cea-3427-5b40-e053-2995a90a0634 2024-06-17 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