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 32 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsExact identifier
application number: M003
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
application number: M003
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS8a9848b0-19df-455a-9984-5ea2e5ce1b9f2026-02-17WarningsExact identifier
application number: M003
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
application number: M003
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
application number: M003
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
application number: M003
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
application number: M003
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnited Natural Foods, Inc. dba UNFI8a44aa29-58d6-4971-b572-4579f03ed2272026-02-17Warnings, Adverse reactionsExact identifier
application number: M003
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEValu Merchandisers Company8235b54f-2468-45ca-bff0-9149e582e8862026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
application number: M003
IodineIODINEUnited Natural Foods, Inc. dba UNFI8e840855-d210-4a99-b73f-6c69dcf2b6fb2026-02-16WarningsExact identifier
application number: M003
IODDO IODINEIODINEEVI LABS4af8552c-1f2b-84ad-e063-6394a90abb622026-02-16WarningsExact 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