Home NDC 53228-050 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 Ingredient Strength BENZETHONIUM CHLORIDE 195 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PH41D05744 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53228-050-01 finipil Lait 50 44 mL in 1 TUBE CREAM 44 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZETHONIUM CHLORIDE ACTIVE INGREDIENT PH41D05744 FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 BENZETHONIUM ACTIVE MOIETY 1VU15B70BP FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 BEHENTRIMONIUM METHOSULFATE INACTIVE INGREDIENT 5SHP745C61 FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 CHLORHEXIDINE GLUCONATE INACTIVE INGREDIENT MOR84MUD8E FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 HAMAMELIS VIRGINIANA TOP INACTIVE INGREDIENT UDA30A2JJY FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 LEVOMENOL INACTIVE INGREDIENT 24WE03BX2T FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 MATRICARIA RECUTITA INACTIVE INGREDIENT G0R4UBI2ZZ FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 MENTHYL LACTATE, (-)- INACTIVE INGREDIENT 2BF9E65L7I FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 POLYQUATERNIUM-37 (25000 MPA.S) INACTIVE INGREDIENT 31L31U8285 FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FINIPIL LAIT 50 (BENZETHONIUM CHLORIDE) CREAM [EQUIBAL, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FINIPIL 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 110 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunmark Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Strategic Sourcing Services LLC c79ae066-8b3b-400d-8b26-f41100e7f534 2023-12-19 Warnings Exact identifier application number: M003 Sunmark Iodides Tincture ETHYL ALCOHOL Strategic Sourcing Services LLC 5e227f79-fca7-4633-97ea-61da4060fe92 2023-12-19 Warnings Exact identifier application number: M003 sunmark Povidone-Iodine Topical POVIDONE-IODINE Strategic Sourcing Services LLC acc349d6-2875-4814-aa6e-828fffec7f07 2023-12-19 Warnings Exact identifier application number: M003 DDM Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Discount Drug Mart 5d538c8e-bf87-d85c-e053-2991aa0af729 2023-12-19 Warnings Exact identifier application number: M003 DDM Decolorized Iodine ETHYL ALCOHOL Discount Drug Mart 5d570ea7-ab08-54b7-e053-2991aa0a7a83 2023-12-19 Warnings Exact identifier application number: M003 DDM Povidone Iodine POVIDONE IODINE 10% Discount Drug Mart 5d161a9d-0462-0afd-e053-2991aa0a22e2 2023-12-19 Warnings Exact identifier application number: M003 HEB Povidone Iodine POVIDONE IODINE 10% H E B 5d576ce2-7d63-c860-e053-2a91aa0a072c 2023-12-18 Warnings Exact identifier application number: M003 Publix Povidone Iodine POVIDONE IODINE 10% Publix 5d6bba46-2571-4957-e053-2a91aa0a2e85 2023-12-18 Warnings Exact identifier application number: M003 Top Care Decolorized Iodine ETHYL ALCOHOL TOPCO ASSOCIATES LLC 5d6bdc17-5c3a-7dec-e053-2991aa0aa450 2023-12-18 Warnings Exact identifier application number: M003 Tincture Merthiolate BENZALKONIUM CHLORIDE DLC Laboratories, Inc 4fec9119-fbbf-4fc7-9122-c6300cac8731 2023-12-18 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL New Pride Corp 0c9e1e9c-b8fc-1932-e063-6394a90a09bf 2023-12-16 Warnings Exact identifier application number: M003 DermaWound Wound Care POVIDONE-IODINE Progressive Doctors, LLC 2d49daa7-aa02-4219-880b-e1697bde8a7e 2023-12-15 Warnings Exact identifier application number: M003 Ethyl Rubbing Alcohol ALCOHOL Humco Holding Group, Inc. 829f3e16-7a9b-4da7-87d2-f58254bda721 2023-12-15 Warnings Exact identifier application number: M003 Humco Iodides Tincture ETHYL ALCOHOL Humco Holding Group, Inc. d230e3a2-1cde-44a9-82c3-3dc5474b3a72 2023-12-15 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Humco Holding Group, Inc. 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Humco Holding Group, Inc. c220b916-6914-435f-84e2-ba828c9916b1 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack ISOPROPYL ALCOHOL Humco Holding Group, Inc. 8de61fdd-8bb9-4845-9129-97bed0686a68 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Merthiolate BENZALKONIUM CHLORIDE Humco Holding Group, Inc. 864063a5-c6cc-4657-9cd6-51af4673bf98 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE SPRAY 5% Humco Holding Group, Inc. a7bb80c4-bbc0-21ea-e053-2995a90a52c1 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 6064c23b-7c15-208d-e053-2991aa0a00f6 2023-12-15 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53228-050-01 53228005001 44 mL in 1 TUBE (53228-050-01) 44 ml 2013-03-01 0000-00-00 No No Current 53228-050-02 53228005002 75 mL in 1 TUBE (53228-050-02) 75 ml 2013-03-01 0000-00-00 No No Current