finipil Lait 50

Product NDC
53228-050
11-digit product format
532280050
Labeler code
53228
Product ID
53228-050_461f32f5-973b-7cf2-e063-6294a90a254b
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 Lait 50
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
bc630fbc-e428-4d46-8330-fb6f699943fdAvailable 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
53228-050-01finipil Lait 5044 mL in 1 TUBECREAM4418

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
BENZETHONIUMACTIVE MOIETY1VU15B70BPFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8EFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
POLYQUATERNIUM-37 (25000 MPA.S)INACTIVE INGREDIENT31L31U8285FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]2

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 111 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
application number: M003
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
application number: M003
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M003
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIALALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0c73f4f5-2b1d-84ae-e063-6394a90a5d7b2023-12-14WarningsExact identifier
application number: M003
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
application number: M003
GNP Idoinde Tincture 2% MildIODINE AND SODIUM IODIDE AND ALCOHOLAmerisource Bergen32ad75b8-abd1-4151-a035-b6c9ae5fc8882023-12-14WarningsExact identifier
application number: M003
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
application number: M003
AntiochPharma Rapidgel Hand SanitizerALCOHOLWeeks & Leo0c57a9ea-de66-3ced-e063-6294a90a4b8d2023-12-12WarningsExact identifier
application number: M003
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
application number: M003
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
application number: M003
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
application number: M003
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
application number: M003
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
application number: M003
FIRSTAR Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.49a86020-b888-423f-99a5-02fa938105ec2023-11-15WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Health4678074a-16f1-5480-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M003
Care One 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLAhold U.S.A., Inc.607b6917-2880-4b1c-83c6-f1297a828ecc2023-11-10WarningsExact identifier
application number: M003
Topcare 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDETopco Associates LLCdc4b07b6-6476-4e32-901a-da8115d6a1972023-11-10WarningsExact identifier
application number: M003
Topcare 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTopco Associates LLCbf9ee7da-69d9-47a2-8748-6b978ca3c2982023-11-10WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd40c7cfc6-ef3b-4759-b9e9-6d7e1319a8472023-11-09WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53228-050-015322800500144 mL in 1 TUBE (53228-050-01) 44 ml2013-03-010000-00-00NoNoCurrent
53228-050-025322800500275 mL in 1 TUBE (53228-050-02) 75 ml2013-03-010000-00-00NoNoCurrent