Home NDC 83165-004 First Aid Antiseptic Pain Relieving Cream
Product NDC 83165-004
11-digit product format 831650004
Labeler code 83165
Product ID 83165-004_52e2d298-ef83-a120-e063-6394a90a2fc6
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Hubei Fanjian Medical Product Co.,Ltd
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
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 Cream
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 83165-004-00 First Aid Antiseptic Pain Relieving Cream 0.9 g in 1 PATCH LIQUID 0.9 3 83165-004-00 First Aid Antiseptic Pain Relieving Cream 1 in 1 PACKAGE LIQUID 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83165-004 FIRST AID ANTISEPTIC PAIN RELIEVING CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) LIQUID [HUBEI FANJIAN MEDICAL PRODUCT CO.,LTD] 2 Current NDC, 2 package rows 20231111_f44aa5a9-45e2-b890-e053-2a95a90a421b.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83165-004-00 83165000400 1 PATCH in 1 PACKAGE (83165-004-00) / .9 g in 1 PATCH 1 patch 2023-01-01 Yes No Current