Mystic

Product NDC
63146-304
Requested package NDC
63146-304-03
11-digit product format
631460304
Labeler code
63146
Product ID
63146-304_ebda98e9-1923-4edb-9159-2205fedea240
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kay Chemical Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-11
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63146-30463146-304-03DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-304MYSTIC (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]5Legacy NDC20240822_29d05188-581a-484c-88a9-84aa9bbfbb93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63146-304-0363146030403750 mL in 1 BOTTLE, PLASTIC (63146-304-03) 750 ml2016-02-110000-00-00NoNoCurrent