Home NDC 34645-5008 BZK
Product NDC 34645-5008
11-digit product format 346455008
Labeler code 34645
Product ID 34645-5008_085c7bca-1ee1-9d63-e063-6294a90a6e18
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SWAB
Route TOPICAL
Labeler Jianerkang Medical Co., Ltd
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-01-01
Substance BENZALKONIUM CHLORIDE
Active strength 1.33 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 34645-5008 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 34645-5008 34645-5008-3 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 BZK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.33 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043307 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 34645-5008-3 BZK 1.4 mL in 1 POUCH SWAB 1.4 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 34645-5008 BZK (BENZALKONIUM CHLORIDE) SWAB [JIANERKANG MEDICAL CO., LTD] 8 Current NDC, Legacy NDC, 1 package rows 20231023_d96c6ad2-c7e9-4079-9db2-59d108f284bb.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 70 of 114 · 2,275 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 34645-5008-3 34645500803 1.4 mL in 1 POUCH (34645-5008-3) 1.4 ml 2006-01-01 0000-00-00 No No Current