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finipil Lait 50 BENZETHONIUM CHLORIDE 195 mg/100mL Cream, 44 mL — NDC 53228-0050-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

finipil Lait 50 BENZETHONIUM CHLORIDE 195 mg/100mL Cream, 44 mL — NDC 53228-050-01 (Billing 53228-0050-01)

by Equibal, Inc. · 44 mL in 1 TUBE

This is a package of 44 mL of finipil Lait 50 BENZETHONIUM CHLORIDE 195 mg/100mL Cream from Equibal, Inc., marketed since Mar 2013 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 53228-0050-01
🏷️ FDA NDC (as labeled) 53228-050-01 billing pads the product segment with a zero
This package
Contains44 mL Pack sizes2 compare ↓
Main listing for product 53228-050 · Also comes in: 75 ml 53228-050-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53228-050-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53228 labeler · 050 product · 01 package
Package marketed since
Mar 1, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5322805001 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53228-050-01
Product NDC 53228-050
11-digit billing NDC 53228005001
UNII PH41D05744
Application # M003
SPL Set ID bc630fbc-e428-4d46-8330-fb6f699943fd
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-01
Route TOPICAL
Dosage form CREAM
Substance BENZETHONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 53228-050-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53228-0050-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Finipil Lait 50 is a topical cream containing benzethonium chloride, an antimicrobial agent. This is an over-the-counter monograph product, meaning it is marketed under FDA's standard rules for its category rather than as an individually reviewed application. Benzethonium chloride is commonly used in topical products to help reduce bacteria and other microorganisms on the skin.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 75 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53228-0050-01 You're viewing this Main listing 44 mL in 1 TUBE 2013-03-01 — Active
53228-0050-02 53228-050-02 75 mL in 1 TUBE 2013-03-01 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 44 mL — 44 ml in 1 tube.
How does this package differ from NDC 53228-0050-02?
Both are finipil Lait 50 BENZETHONIUM CHLORIDE 195 mg/100mL Cream — the drug itself is identical. This page's package is the 44 mL one, while NDC 53228-0050-02 is the 75 ml package.
What NDC number is used to bill for this package of finipil Lait 50 BENZETHONIUM CHLORIDE 195 mg/100mL Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
finipil pro/elec 195 mg/100mL 53228-0001-01 Equibal, 75 ml — — FDA listed —
finipil Lait 50 195 mg/100mLthis 53228-0050-01 Equibal, 44 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Mar 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5SHP745C61
    A quaternary ammonium compound used as an antistatic agent and conditioning ingredient in solid dosage forms. It reduces static electricity buildup during manufacturing and helps improve the texture and flow of powders and granules in tablets or capsules.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII MOR84MUD8E
    Chlorhexidine digluconate is an antimicrobial compound added to some medicines as a preservative to prevent bacterial and fungal growth, extending shelf life and maintaining product safety.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII UDA30A2JJY
    A plant extract from witch hazel used as an astringent and skin-conditioning agent in topical formulations. It helps tone and soothe the skin while functioning as a natural preservative.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII G0R4UBI2ZZ
    Matricaria chamomilla, commonly known as chamomile, is a plant extract used in medicines as a flavoring agent and natural fragrance component. It may also provide mild soothing properties to the formulation.
  • UNII 2BF9E65L7I
    A chemical compound combining menthol with lactic acid. It's used in medicines as a flavoring agent and to provide a cooling or soothing sensation on the skin or mouth.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 31L31U8285
    A synthetic polymer that thickens and stabilizes liquid formulations. It's used as a viscosity enhancer and suspending agent to keep ingredients evenly distributed and improve the product's texture and consistency.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

14 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients Behentrimonium methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutita) Extract, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquarternium-37, Stearic Acid, Witch Hazel (Hamamelis Virginiana) Extract

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEquibal, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code53228
First marketedMar 2013
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Equibal, Inc. labeler code 53228

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Use(s) Use(s) first aid to help prevent bacterial contamination in minor cuts, scrapes and burns. cools, soothes and moisturizes after hair removal. recommended for repeated use.

⏱️ Dosage and Administration 13 words ▾

Directions Directions Apply a small amount of this product on the area daily.

⚠️ Warnings 20 words ▾

Warnings Do not use in conjunction Warnings For external use only Do not use in conjunction with products containing acids

🧪 Active Ingredient 10 words ▾

Active Ingredient DRUG FACTS Active Ingredient Benzethonium Chloride 0.2% w/w

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients Inactive ingredients Behentrimonium methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutita) Extract, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquarternium-37, Stearic Acid, Witch Hazel (Hamamelis Virginiana) Extract

🎯 Purpose 3 words ▾

Purpose Purpose Antiseptic

📄 When Using This Product 21 words ▾

When using this product When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if Stop use and ask a doctor if irritation and redness develop

🤰 If Pregnant or Breast-Feeding 12 words ▾

Ask a doctor if Ask a doctor if pregnant or breast feeding,

📄 Keep Out of Reach of Children 25 words ▾

Keep out of reach of children. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 187 words ▾

finipil LAIT 50 Product Label finipil ® soothes antiseptic moisturizes cream protects against infection LAIT 50 ● ● ● Noncomedogenic 1.5 fl oz 44 ml DRUG FACTS Active Ingredient Purpose Benzethonium Chloride 0.2% w/w Antiseptic Uses(s) first aid to help prevent bacterial contamination in minor cuts, scrapes, and burns. cools, soothes, and moisturizes after hair removal. recommended for repeated use. Warnings For external use only Ask a doctor if pregnant or breast feeding. When using this product do not get into eyes. if contact occurs, rinse eyes thoroughly with water Stop use and ask a doctor if irritation and redness develop Do not use in conjunction with products containing acids.

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away. Directions Apply a small amount of this product on the area daily. Inactive Ingredients Behentrimonium Methosulfate, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Matricaria (Chamomile Recutital) Extract, Menthyl Lactate, Octylodecanoil, Phenoxyethanol, Polyquaterniuim-37, Stearic Acid, Water, Witch Hazel (Hamamelis Virginiana) Extract equibal labs 800-247-2405 nufree.com Made in U.S.A. not tested on animals patent# 8,603,550 Packaging 2.5oz Packaging 1.5oz

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for finipil Lait 50 (this brand).

Top reported reactions

Nausea23
Hypersensitivity20
Headache18
Therapeutic Product Effect Decreased17
Contraindicated Product Administered10
Diarrhoea6
Death5

Age at onset

Child1
Adult7
Elderly13

Reporter sex

85 reports
Male · 38%
Female · 62%

Serious outcomes

Death17
Life-threatening3
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 12 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Equibal, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 75 ml (53228-0050-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Equibal, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 53228-0003-01 · Equibal, 53228-0230-01 · Equibal, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.