Home NDC 41190-278 Benzalkonium chloride
Product NDC 41190-278
11-digit product format 411900278
Labeler code 41190
Product ID 41190-278_4aba51f7-3d76-5de4-e063-6294a90a1484
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride 0.13%
Dosage form SOAP
Route TOPICAL
Labeler Wakefern Food Corp.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-10
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 g/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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 Benzalkonium chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 g/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 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 41190-278-03 Benzalkonium chloride 1470 mL in 1 BOTTLE, PLASTIC SOAP 1470 14 41190-278-68 Benzalkonium chloride 1650 mL in 1 BOTTLE, PUMP SOAP 1650 14 41190-278-96 Benzalkonium chloride 221 mL in 1 BOTTLE, PUMP SOAP 221 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41190-278 BENZALKONIUM CHLORIDE (BENZALKONIUM CHLORIDE 0.13%) SOAP [WAKEFERN FOOD CORP] 12 Current NDC, Legacy NDC, 3 package rows 20241001_d4e823bc-527b-4815-a7e0-47ee8d004e63.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41190-278-03 41190027803 1470 mL in 1 BOTTLE, PLASTIC (41190-278-03) 1470 ml 2017-07-10 0000-00-00 No No Current 41190-278-68 41190027868 1650 mL in 1 BOTTLE, PUMP (41190-278-68) 1650 ml 2017-07-10 0000-00-00 No No Current 41190-278-96 41190027896 221 mL in 1 BOTTLE, PUMP (41190-278-96) 221 ml 2017-07-10 0000-00-00 No No Current