finipil pro/elec

Product NDC
53228-001
11-digit product format
532280001
Labeler code
53228
Product ID
53228-001_46332a46-c1c3-3043-e063-6394a90ae90f
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 pro/elec
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
53228-001-01finipil pro/elec75 mL in 1 TUBECREAM7515
53228-001-02finipil pro/elec3.6 mL in 1 PACKETCREAM3.615
53228-001-03finipil pro/elec236 mL in 1 BOTTLE, PUMPCREAM23615

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744FINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61FINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8EFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
POLYQUATERNIUM-37 (25000 MPA.S)INACTIVE INGREDIENT31L31U8285FINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFINIPIL PRO/ELEC (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53228-001-015322800010175 mL in 1 TUBE (53228-001-01) 75 ml2013-03-010000-00-00NoNoCurrent
53228-001-02532280001023.6 mL in 1 PACKET (53228-001-02) 3.6 ml2013-03-010000-00-00NoNoCurrent
53228-001-0353228000103236 mL in 1 BOTTLE, PUMP (53228-001-03) 236 ml2013-03-010000-00-00NoNoCurrent