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

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 Identifiers#

Field, Values table
FieldValues
UniiPH41D05744

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

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