Home NDC 84219-002 First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride
Product NDC 84219-002
11-digit product format 842190002
Labeler code 84219
Product ID 84219-002_150780a1-835b-7941-e063-6394a90ab9f5
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler M-star (Hubei) Health&Care Products Co., Ltd.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-15
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 2027-12-31
Current FDA listing Yes 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 First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84219-002-00 First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride 0.9 g in 1 POUCH CREAM 0.9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84219-002 FIRST AID ANTISEPTIC PAIN RELIEVING BENZALKONIUM CHLORIDE LIDOCAINE HYDROCHLORIDE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.] 1 Current NDC, 1 package rows 20240515_8e1f35ff-d4e6-4940-ad8f-dce2b73e595d.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 110 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join sunmark Povidone-Iodine Topical POVIDONE-IODINE Strategic Sourcing Services LLC acc349d6-2875-4814-aa6e-828fffec7f07 2023-12-19 Warnings Exact identifier application number: M003 DDM Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Discount Drug Mart 5d538c8e-bf87-d85c-e053-2991aa0af729 2023-12-19 Warnings Exact identifier application number: M003 DDM Decolorized Iodine ETHYL ALCOHOL Discount Drug Mart 5d570ea7-ab08-54b7-e053-2991aa0a7a83 2023-12-19 Warnings Exact identifier application number: M003 DDM Povidone Iodine POVIDONE IODINE 10% Discount Drug Mart 5d161a9d-0462-0afd-e053-2991aa0a22e2 2023-12-19 Warnings Exact identifier application number: M003 HEB Povidone Iodine POVIDONE IODINE 10% H E B 5d576ce2-7d63-c860-e053-2a91aa0a072c 2023-12-18 Warnings Exact identifier application number: M003 Publix Povidone Iodine POVIDONE IODINE 10% Publix 5d6bba46-2571-4957-e053-2a91aa0a2e85 2023-12-18 Warnings Exact identifier application number: M003 Top Care Decolorized Iodine ETHYL ALCOHOL TOPCO ASSOCIATES LLC 5d6bdc17-5c3a-7dec-e053-2991aa0aa450 2023-12-18 Warnings Exact identifier application number: M003 Tincture Merthiolate BENZALKONIUM CHLORIDE DLC Laboratories, Inc 4fec9119-fbbf-4fc7-9122-c6300cac8731 2023-12-18 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL New Pride Corp 0c9e1e9c-b8fc-1932-e063-6394a90a09bf 2023-12-16 Warnings Exact identifier application number: M003 DermaWound Wound Care POVIDONE-IODINE Progressive Doctors, LLC 2d49daa7-aa02-4219-880b-e1697bde8a7e 2023-12-15 Warnings Exact identifier application number: M003 Ethyl Rubbing Alcohol ALCOHOL Humco Holding Group, Inc. 829f3e16-7a9b-4da7-87d2-f58254bda721 2023-12-15 Warnings Exact identifier application number: M003 Humco Iodides Tincture ETHYL ALCOHOL Humco Holding Group, Inc. d230e3a2-1cde-44a9-82c3-3dc5474b3a72 2023-12-15 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Humco Holding Group, Inc. 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Humco Holding Group, Inc. c220b916-6914-435f-84e2-ba828c9916b1 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack ISOPROPYL ALCOHOL Humco Holding Group, Inc. 8de61fdd-8bb9-4845-9129-97bed0686a68 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Merthiolate BENZALKONIUM CHLORIDE Humco Holding Group, Inc. 864063a5-c6cc-4657-9cd6-51af4673bf98 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE SPRAY 5% Humco Holding Group, Inc. a7bb80c4-bbc0-21ea-e053-2995a90a52c1 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 6064c23b-7c15-208d-e053-2991aa0a00f6 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE GARGLE 0.5% Humco Holding Group, Inc. a7b9ad55-cfeb-6066-e053-2a95a90af975 2023-12-15 Warnings Exact identifier application number: M003 Rite Aid Povidone Iodine POVIDONE IODINE 10% Rite Aid Corporation 5df6ff37-a4ea-d666-e053-2991aa0a9786 2023-12-15 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 Sample Exclude flag Status 84219-002-00 84219000200 .9 g in 1 POUCH (84219-002-00) 2024-05-15 No No Current