FDA.reportPublic FDA data

finipil 4 men only

Product NDC
53228-231
Requested package NDC
53228-231-01
11-digit product format
532280231
Labeler code
53228
Product ID
53228-231_463269d3-0c65-62e1-e063-6394a90a1c6b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Equibal, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-01
Substance
BENZETHONIUM CHLORIDE
Active strength
200 mg/1000mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
finipil 4 men only
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE200 mg/1000mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aba2e3e6-6047-416d-8ca3-44f1033671e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53228-231-01finipil 4 men only236000 mg in 1 BOTTLE, PUMPLIQUID23600012
53228-231-02finipil 4 men only118000 mg in 1 BOTTLE, PUMPLIQUID11800012

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 50 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
application number: M003
DEYODISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.b147ed5b-ab6e-ca00-e053-2a95a90ae01a2025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC1ea56ac9-4fc2-41c0-adda-5a2c55bef6962025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC847b9edc-74e6-43fd-83cd-43e6712780c62025-12-10WarningsExact identifier
application number: M003
The Pharma-C Company 70 Isopropyl Alcohol PadsISOPROPYL ALCOHOLKleen Test Products Corporationc5df867b-1b8d-4e38-8c32-7d528b9825902025-12-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
application number: M003
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
application number: M003
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
application number: M003
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
application number: M003
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53228-231-0153228023101236000 mg in 1 BOTTLE, PUMP (53228-231-01) 236000 mg2014-08-010000-00-00NoNoCurrent