FDA.reportPublic FDA data

finipil 4 men only

Product NDC
53228-231
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 67 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
application number: M003
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6ad099-c770-064f-e063-6294a90a222d2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef24-f162-5549-e063-6294a90a30b82025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef38-215c-defa-e063-6394a90a46a62025-09-09WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e44c28e-c6ed-52b4-e063-6394a90a9dd02025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer My Little PonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e45fe7d-b30c-9273-e063-6294a90ae8e12025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer Peppa pigALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e466475-351f-614e-e063-6394a90ab25a2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e46fe11-247f-36ad-e063-6294a90a1dd42025-09-08WarningsExact identifier
application number: M003
Green Guard Super Stat Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEUnifirst First Aid Corporation47355df2-de67-4cf9-b367-645228e494ce2025-09-08WarningsExact identifier
application number: M003
Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEUnifirst First Aid Corporation2e544963-aa49-49cd-837e-9d89d86e257f2025-09-08WarningsExact identifier
application number: M003
Medi-first Protective Coating BandageBENZETHONIUM CHLORIDE AND BENZOCAINEUnifirst First Aid Corporation05b0aef9-1553-4e95-8798-f41e5999bb462025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporation3f7fb451-e701-4aa8-814e-ceeb5c2198d92025-09-08WarningsExact identifier
application number: M003
Medi-First Plus Alcohol Wipes70% ISOPROPYL ALCOHOLUnifirst First Aid Corporation3f507990-282a-4b26-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M003
Green Guard Sterile Alcohol WipesISOPROPYL ALCOHOL 70%Unifirst First Aid Corporation570baa70-e519-328b-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M003
Medi-First Plus Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporation5743634b-f329-5fec-e053-2991aa0a751d2025-09-08WarningsExact identifier
application number: M003
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUniFirst First Aid Corporation1bdd57c3-cdaf-a085-e063-6394a90a1e3d2025-09-08WarningsExact 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
53228-231-0253228023102118000 mg in 1 BOTTLE, PUMP (53228-231-02) 118000 mg2014-08-010000-00-00NoNoCurrent