FDA.reportPublic FDA data

finipil pro/elec

Product NDC
53228-001
11-digit product format
532280001
Labeler code
53228
Product ID
53228-001_46332a46-c1c3-3043-e063-6394a90ae90f
Type
HUMAN OTC DRUG
Nonproprietary name
BENZETHONIUM CHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Equibal, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
Substance
BENZETHONIUM CHLORIDE
Active strength
195 mg/100mL
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 pro/elec
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE195 mg/100mL

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
f68aa5db-7a4e-410f-8159-3356d9407d31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53228-001-01finipil pro/elec75 mL in 1 TUBECREAM7515
53228-001-02finipil pro/elec3.6 mL in 1 PACKETCREAM3.615
53228-001-03finipil pro/elec236 mL in 1 BOTTLE, PUMPCREAM23615

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744FINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61FINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8EFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
POLYQUATERNIUM-37 (25000 MPA.S)INACTIVE INGREDIENT31L31U8285FINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1

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 22 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lucys Renewals Skin and Nails First Aid AntisepticBENZETHONIUM CHLORIDEACP Laboratories LLCa702297d-8f7e-4019-a987-7bd83becb5ee2026-05-07WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsExact identifier
application number: M003
Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEAmbition Power Brands5132bc70-bf3b-180c-e063-6394a90afdad2026-05-06WarningsExact identifier
application number: M003
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsExact identifier
application number: M003
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
application number: M003
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDENantong Health & Beyond Hygienic Products Inc.cb97ba55-d678-4e43-aa85-37e9f530e9112026-05-04WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDEEVERLIT GLOBAL INC.4873b106-4ea2-412c-a7ab-756a111959842026-05-04WarningsExact identifier
application number: M003
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin ProseccoALCOHOLScent Theory Products LLC50f03829-eda8-3a25-e063-6294a90a6fd22026-05-03WarningsExact identifier
application number: M003
DUBBLE BUBBLE HAND SANITIZER BUBBLE GUMALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52084e0a-ffe2-83f4-e063-6294a90a305e2026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANI BIRTHDAY CAKEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520828a5-4e8d-b637-e063-6394a90ab4912026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI BLUE RASBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b5-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27da-81a3-e063-6294a90afc802026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b6-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208bd2c-277c-648e-e063-6294a90a5b282026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52092127-7a8d-5db3-e063-6294a90a07b52026-05-01WarningsExact identifier
application number: M003
Liquid death hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520943a4-0e63-a9ab-e063-6394a90ab2a92026-05-01WarningsExact identifier
application number: M003
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53228-001-015322800010175 mL in 1 TUBE (53228-001-01) 75 ml2013-03-010000-00-00NoNoCurrent
53228-001-02532280001023.6 mL in 1 PACKET (53228-001-02) 3.6 ml2013-03-010000-00-00NoNoCurrent
53228-001-0353228000103236 mL in 1 BOTTLE, PUMP (53228-001-03) 236 ml2013-03-010000-00-00NoNoCurrent