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 88 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003
Easy Care Hand SanitizerALCOHOLGFA Production (Xiamen) Co., Ltd.c7058806-ad4e-6d5f-e053-2a95a90a35e82025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Rejoice International Corp.04fd3bbe-1729-a748-e063-6394a90a96552025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Rejoice International Corp.04fd9665-a6b3-678a-e063-6294a90a60a52025-01-27WarningsExact identifier
application number: M003
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
application number: M003
Germstar Premium Hand SanitizerETHYL ALCOHOLSoaptronic LLC489652af-7333-628a-e054-00144ff8d46c2025-01-24WarningsExact identifier
application number: M003
Little Buddy in a Little TubbyHAND SANITIZING TOWELETTESContinental Research Corpf4fac964-4a27-335d-e053-2a95a90ac4eb2025-01-23WarningsExact identifier
application number: M003
PHARMACYS PRESCRIPTION 8OZ HAND SANITIZERALCOHOLAmerican Consumer Products Corp7a048607-f4c3-6724-e053-2a91aa0ab6f22025-01-23WarningsExact identifier
application number: M003
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERAALCOHOLAmerican Consumer Products Corpa8f00148-b8fa-6c4f-e053-2995a90ac5e22025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa9ca8aaa-ea76-7eb5-e053-2995a90adef92025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa8c6ef84-b072-72ee-e053-2995a90aa1112025-01-23WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Rejoice International Corp.052031f9-5206-c1bc-e063-6394a90ab0f22025-01-23WarningsExact 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