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 86 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Coconut and Lime 3ozALCOHOLNingbo Rejoice Internationalbc07a905-b740-5e44-e053-2a95a90a4db92025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber and Melon 3ozALCOHOLNingbo Rejoice Internationalbc0810e9-2381-4212-e053-2995a90a264e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Pomegranate and Vanilla 3ozALCOHOLNingbo Rejoice Internationalbc082139-f868-2f20-e053-2995a90ab9462025-02-13WarningsExact identifier
application number: M003
Rubbing Alcohol 91 percent isopropylISOPROPYL ALCOHOLWinCo Foods, LLC0ce2110d-ea9d-4d41-b0ae-6e9182f25abc2025-02-12WarningsExact identifier
application number: M003
XtraCare Wet WipesBENZETHONIUM CHLORIDERejoice International3741acc3-c590-4bf1-8c83-4f812e2c7adc2025-02-12WarningsExact identifier
application number: M003
Wet WipesBENZETHONIUM CHLORIDERejoice Internationalb4952aa6-a305-42df-b67e-82905be8a92d2025-02-12WarningsExact identifier
application number: M003
Wet WipesBENZETHONIUM CHLORIDERejoice International0ffcf0c2-409f-4dea-b296-b5ccb61399df2025-02-12WarningsExact identifier
application number: M003
Wet WipesBENZETHONIUM CHLORIDERejoice International5bdffa77-143d-4783-9aa4-971c084a94f52025-02-12WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Fresh CitrusTRICLOSANRejoice International, Inc.e87ef6e6-ef41-43c4-bfdf-b7e3446436b72025-02-12WarningsExact identifier
application number: M003
XtraCare Cucumber MelonETHYL ALCOHOLRejoice International021fa2a0-d2ea-4699-a3d8-3c0af18c5aa32025-02-12WarningsExact identifier
application number: M003
XtraCare Lavender ChamomileETHYL ALCOHOLRejoice International6e611e87-1835-49f8-aa52-b724bd2515272025-02-12WarningsExact identifier
application number: M003
XtraCare Sweet Pea BlossomETHYL ALCOHOLRejoice International1a5408f2-910c-4c6a-b6b3-c1304dd1cdf02025-02-12WarningsExact identifier
application number: M003
XtraCare Warm VanillaETHYL ALCOHOLRejoice International46e7b4fa-3722-4487-9325-f8552ea92acf2025-02-12WarningsExact identifier
application number: M003
Instant Hand Sanitizer 2oz Bonus packETHYL ALCOHOLRejoice International Inc.5b209df6-d896-170c-e053-2a91aa0a52a82025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e62eb50-ebb8-361e-e053-2991aa0aba6f2025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e6585a3-61e1-30ec-e053-2a91aa0a60392025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Spider Man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dedab76-3f5a-febf-e063-6394a90a69932025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e65856c-0e14-1ab6-e053-2991aa0a3f3e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd2ffd-a85a-f63e-e063-6294a90a6a5e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd4acb-451b-12d3-e063-6294a90a48732025-02-12WarningsExact 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