FDA.reportPublic FDA data

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 90 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact 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