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 91 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLCf80ccd8a-9b9b-bbf9-e053-6394a90ac8272024-12-20WarningsExact identifier
application number: M003
All Good Rose Geranium Hand SanitizerETHYL ALCOHOLElemental Herbs, Inc.f9b93df2-e28d-840e-e053-6294a90ae48a2024-12-20WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf0f12204-2948-1357-e053-2995a90ae50a2024-12-19WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLNew Pride Corpf0f223b9-fa98-f118-e053-2a95a90a1ac72024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Products3c32b817-39fa-4801-9f40-6073b3e188552024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 99% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsd196bef3-625a-b7d5-e053-2995a90afe6c2024-12-19WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLHome Smart Productscfe4fca2-bb20-4ab3-b304-32d9ba0451f62024-12-19WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHome Smart Products9cc0767c-b9aa-42c1-b183-a35f2560942b2024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf159051c-27de-52a9-e053-2995a90aeb722024-12-19WarningsExact identifier
application number: M003
91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf15a6843-78bd-223c-e053-2a95a90a20332024-12-19WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf158ad51-b772-257f-e053-2a95a90a55582024-12-19WarningsExact 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