FDA.reportPublic FDA data

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

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 pro/elec
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
f68aa5db-7a4e-410f-8159-3356d9407d31Available 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
53228-001-01finipil 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

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 68 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb3ef1ef5-1f6f-874a-e053-2995a90a32b12025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationa0f58025-2c50-45dc-94db-cacbd4cf604c2025-09-08WarningsExact identifier
application number: M003
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
application number: M003
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationb4627f3f-6282-51bf-e053-2a95a90a3d592025-09-08WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb463d09c-4b33-3774-e053-2a95a90a046b2025-09-08WarningsExact identifier
application number: M003
Thompson Burn Cream with LidocainBENZALKONIUM CHLORIDE, LIDOCAINEThompson Safety11729e6b-b911-5c1f-e063-6394a90a0c342025-09-08WarningsExact identifier
application number: M003
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2869cb20-9cd4-54f5-e063-6294a90a5fea2025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.28694168-3362-de4f-e063-6394a90a2e352025-09-05WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e0a5382-7b58-fd6e-e063-6394a90abf662025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e09c0aa-0241-0816-e063-6294a90a481e2025-09-05WarningsExact identifier
application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3080d8a2-a780-e79b-e063-6294a90ac6542025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3081e1b5-66b4-77a8-e063-6394a90a8dd32025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30847dd5-e378-1a35-e063-6294a90a43da2025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3084d980-29ca-91ca-e063-6294a90a6c672025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3099e6af-8072-d26b-e063-6394a90a39ef2025-09-05WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINESion Biotext Medical Ltde05af551-647d-4278-bb7f-86f888ddbb8b2025-09-04WarningsExact identifier
application number: M003
X3 CleanBENZALKONIUM CHLORIDEX3 Labs Inc.a8eedcfd-3b97-497a-9a34-d59b0dd784392025-09-03WarningsExact identifier
application number: M003

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