Home NDC 53329-918 Medline
Product NDC 53329-918
11-digit product format 533290918
Labeler code 53329
Product ID 53329-918_414bb528-1926-c545-e063-6394a90ad391
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride, lidocain hydrochloride
Dosage form SPRAY
Route TOPICAL
Labeler Medline Industries, LP
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength .13; 4 g/100g; g/100g
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 53329-918 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53329-918 53329-918-04 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Medline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100g LIDOCAINE HYDROCHLORIDE 4 g/100g
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 2047877 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 53329-918-04 Medline 113 g in 1 BOTTLE, SPRAY SPRAY 113 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-918 MEDLINE (BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE) SPRAY [MEDLINE INDUSTRIES, LP] 5 Current NDC, Legacy NDC, 1 package rows 20241213_b1059e68-b240-056c-e053-2995a90a61b2.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 101 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-918-04 53329091804 113 g in 1 BOTTLE, SPRAY (53329-918-04) 113 g 2021-05-01 0000-00-00 No No Current