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 9 of 115 · 2,286 matching rows.
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