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 85 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer 1.8 oz Lemon IceETHYL ALCOHOLNingbo Rejoice Internationala266624f-2175-2fd4-e053-2995a90a33052025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.ETHYL ALCOHOLNingbo Rejoice Internationala2677a83-8f9a-7470-e053-2a95a90aa2892025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala2695f96-ef8c-bba6-e053-2a95a90a243e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 1.8 ozETHYL ALCOHOLNingbo Rejoice Internationala26a866a-bb5f-4b5f-e053-2995a90a97452025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala269e72d-c74b-71ed-e053-2995a90ac1472025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala269a222-95cb-098c-e053-2995a90a21e72025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala346ebd2-fc31-b574-e053-2995a90a0d3a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala7364361-f8ad-fc71-e053-2995a90a68a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala73698ca-2097-3f7d-e053-2a95a90a638a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lemon 2ozALCOHOLNingbo Rejoice Internationalb08ea7ef-a595-6bef-e053-2a95a90a68fb2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 8ozALCOHOLNingbo Rejoice Internationalb08ec92b-e63e-2dab-e053-2995a90a09482025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer with Clip 1.8ozALCOHOLNingbo Rejoice Internationalb08f2909-467d-719d-e053-2995a90a11a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f2993-f166-1a0e-e053-2a95a90a93792025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f3bf1-f55f-5c68-e053-2a95a90ac3ac2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f6f48-796b-3b40-e053-2a95a90a75f62025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f62b0-98dd-5aac-e053-2a95a90a6d8a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer PouchALCOHOLNingbo Rejoice Internationalb08f8faa-d9d6-5b8d-e053-2a95a90a407c2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 24ct PouchALCOHOLNingbo Rejoice Internationalb08fb47c-7241-45d3-e053-2a95a90a8a942025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2ozALCOHOLNingbo Rejoice Internationalb08fd11a-48e2-67b6-e053-2995a90ac3992025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 8ozALCOHOLNingbo Rejoice Internationalb1914c86-4489-fbb8-e053-2995a90a5cd62025-02-13WarningsExact 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