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 104 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Swabs ISOPROPYL ALCOHOL McKesson 4650c945-8e38-5ad9-e054-00144ff8d46c 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER COCONUT BREEZE ALCOHOL SCENT THEORY PRODUCTS LLC 1a5152b3-d674-f69a-e063-6394a90a6cac 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER REBEL CHERRY ALCOHOL SCENT THEORY PRODUCTS LLC 1a503858-4d2f-8e32-e063-6294a90ade97 2024-06-07 Warnings Exact identifier application number: M003 Antiseptic Wipe BENZALKONIUM CHLORIDE Jianerkang Medical Co., Ltd 1a3c5fc9-70cc-e857-e063-6294a90a3424 2024-06-06 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Wildman Business Group 1f95b277-e40c-4a17-e063-6294a90a1127 2024-06-01 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. dbfdecf0-a961-4cc5-bf87-ae30bbc302dd 2024-05-31 Warnings Exact identifier application number: M003 hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a6c3c6-4b27-9011-e063-6394a90ae512 2024-05-30 Warnings Exact identifier application number: M003 antibacterial hand sanitizer gel 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a7b2fc-239c-b53c-e063-6394a90a0906 2024-05-30 Warnings Exact identifier application number: M003 MyMedic Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. 197fc623-2fb9-184c-e063-6394a90a4104 2024-05-28 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Limon ALCOHOL Noshinku d70fba7a-513f-0341-e053-2a95a90add86 2024-05-15 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Vetiver ALCOHOL Noshinku d70fb84c-fdbc-6ba8-e053-2995a90ab529 2024-05-15 Warnings Exact identifier application number: M003 Safly BZK Antiseptic Towelette BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 5cd9043e-daf2-43eb-9568-54775fc4f84a 2024-05-15 Warnings Exact identifier application number: M003 Noshinku Bergamot Hand Sanitizer ALCOHOL Noshinku 53fea81e-4482-6fae-e054-00144ff8d46c 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Eucalyptus Hand Sanitizer ALCOHOL Noshinku 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Lavender Hand Sanitizer ALCOHOL Noshinku a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf 2024-05-14 Warnings Exact identifier application number: M003 LEADER 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Cardinal Health, 110 dba Leader 7f810b92-60f6-2f72-e053-2991aa0ab973 2024-05-13 Warnings Exact identifier application number: M003 Leader Decolorized Iodine ALCOHOL LIQUID Cardinal Health, 110 dba Leader 822f6f28-956f-dd82-e053-2991aa0ae752 2024-05-13 Warnings Exact identifier application number: M003 Inverness Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a2995-334c-2e93-e063-6294a90aecf7 2024-05-09 Warnings Exact identifier application number: M003 Helzberg Diamonds Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a3776-0edd-26f3-e063-6294a90a740d 2024-05-09 Warnings Exact identifier application number: M003 Ulta Beauty Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a37f4-8718-3e40-e063-6294a90acaad 2024-05-09 Warnings Exact identifier application number: M003
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