FDA.reportPublic FDA data

BAC OFF

Product NDC
64495-2365
Requested package NDC
64495-2365-1
11-digit product format
644952365
Labeler code
64495
Product ID
64495-2365_ed1fbafc-9164-84eb-e053-2995a90a47c8
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Wayne Concept Manufacturing Co Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-03-30
Marketing end
2022-12-15
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64495-236564495-2365-1DDiscontinued by firm2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7BAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YBAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPBAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1
DIHYDROXYETHYL COCAMINE OXIDEINACTIVE INGREDIENT8AR51R3BL5BAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1
LAURTRIMONIUM CHLORIDEINACTIVE INGREDIENTA81MSI0FICBAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64495-2365-1644952365013785 mL in 1 BOTTLE, PLASTIC (64495-2365-1) 3785 ml2018-11-212022-12-15NoNoCurrent