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Avene Cleanance Acne Medicated Clearing Treatment BENZOYL PEROXIDE 5.5 mg/40mL Liquid — NDC 64760-0776-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Avene Cleanance Acne Medicated Clearing Treatment BENZOYL PEROXIDE 5.5 mg/40mL Liquid — NDC 64760-776-01 (Billing 64760-0776-01)

by Pierre Fabre USA Inc. · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Avene Cleanance Acne Medicated Clearing Treatment BENZOYL PEROXIDE 5.5 mg/40mL Liquid from Pierre Fabre USA Inc., marketed since May 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 64760-0776-01
🏷️ FDA NDC (as labeled) 64760-776-01 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 64760-776 · Also comes in: 40 mL 64760-776-02
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 →
⚠️
Other active recalls for Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64760-776-01
Product NDC 64760-776
11-digit billing NDC 64760077601
UNII W9WZN9A0GM
Application # M006
SPL Set ID facb99a0-f67e-80bf-e053-6294a90a2332
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-30
Route TOPICAL
Dosage form LIQUID
Substance BENZOYL PEROXIDE
Why two NDCs? The FDA registers this code as 64760-776-01 — 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 → 64760-0776-01. 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

📗 Our plain-language guide HelloPharmacist
  • Most products are for acne. They dry up pimples and help prevent new ones. Epsolay is a prescription cream for rosacea bumps in adults. The Folliculitis Treatment Cream products ar...
  • For many acne products, start with once a day. You can move up to two or three times daily if your skin tolerates it. If you get dryness or peeling, cut back to once daily or every...
  • Redness, dryness, peeling, itching, and stinging or burning are the usual ones. Using less often can help. Using another acne product at the same time makes irritation more likely.
  • Stop if irritation gets severe. Stop right away and get help if you have hives, swelling or trouble breathing. Those can be signs of a serious allergic reaction.
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

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 mLPer 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: 40 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
64760-0776-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE Sample 2023-05-30 — Active
64760-0776-02 64760-776-02 1 BOTTLE in 1 CARTON / 40 mL in 1 BOTTLE 2023-05-30 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 5 ml in 1 bottle.
What NDC number is used to bill for this package of Avene Cleanance Acne Medicated Clearing Treatment BENZOYL PEROXIDE 5.5 mg/40mL Liquid?
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
Avene Cleanance Acne Medicated Clearing Treatment 5.5 mg/40mLthis 64760-0776-01 Pierre 1 bottle — — 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 809Y72KV36
    A synthetic polymer made from acrylic acid and crosslinked with allyl pentaerythritol. It's used as a thickening agent and gelling ingredient in creams, gels, and lotions to create the proper texture and help the medicine spread and stay on the skin.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 7YY1T561V4
    A surfactant derived from succinic acid, used as a wetting agent and emulsifier to help distribute water-soluble and oily ingredients evenly throughout the formulation.
  • 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 SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII WUG58TD53X
    A natural ingredient derived from dragon fruit, used as a colorant and flavoring agent in medicines. It provides red or pink color and subtle fruit flavor to tablets or liquids.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII 7829X3G2X5
    A plant extract from the morinda citrifolia fruit, used as a natural flavoring agent and colorant in medicines. It may also provide antioxidant properties to help preserve the product's stability.
  • UNII HD40WR33LC
    A synthetic liquid compound made from polyethylene glycol and sorbitan stearate. It acts as an emulsifier to blend oil and water-based ingredients together, and also helps the medicine dissolve or disperse properly.
  • UNII ECU18C66Q7
    PEG-40 stearate is a synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves and is absorbed.
  • 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 7B8OE71MQC
    A synthetic emulsifier derived from glycerin and fatty acids. It helps oils and water mix together in formulations, keeping ingredients evenly distributed throughout the product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 5F4963KLHS
    A synthetic polymer created from acrylamide and sodium acryloyldimethyltaurate that thickens and stabilizes liquid or semi-solid formulations. It helps maintain consistent texture and prevents separation of ingredients in creams, gels, and lotions.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater (aqua), propanediol, dimethyl isosorbide, glycerin, 1,2-hexanediol, acrylamide/sodium acryloyldimethyllurate copolymer, isohexadecane, hydroxyacetophenone, hylocereus undatus fruit extract, polysorbate 80, polyglyceryl-2 isostearate, xanthan gum, sodium citrate, trisodium ethylenediamine disuccinate, citric acid, diethylhexyl sodium sulfosuccinate, carbomer, sodium hydroxide, hyaluronic acid, ethylhexylglycerin, morinda citrifolia extract, phenoxyethanol, dimethicone, sodium metabisulfite, peg-40 stearate, silica, sorbitan stearate, tocopherol

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

LabelerPierre Fabre USA Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code64760
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio12 products on file
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 24 words ▾

Uses For the treatment of acne. Dries and clears acne blemishes and allows skin to heal. Helps keep skin clear of new acne blemishes

⏱️ Dosage and Administration 91 words ▾

Directions clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer one to three times daily. because excessive dry of the skin may occur, start with one application daily, then gradually increase to two or three times daily needed or as directed by a doctor. if bothersome dryness or peeling occurs reduce application to once a day or every other day. if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 143 words ▾

Warnings For external use only. Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide. When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

If irritation occurs, only use one topical acne medication at a time. Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with the eyes, lips, and mouth.

Avoid contact with hair and dyed fabrics, which may be bleached by this product. Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor If irritation becomes severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient BENZOYL PEROXIDE 5.5%

🧪 Inactive Ingredients 53 words ▾

Inactive Ingredients Water (aqua), propanediol, dimethyl isosorbide, glycerin, 1,2-hexanediol, acrylamide/sodium acryloyldimethyllurate copolymer, isohexadecane, hydroxyacetophenone, hylocereus undatus fruit extract, polysorbate 80, polyglyceryl-2 isostearate, xanthan gum, sodium citrate, trisodium ethylenediamine disuccinate, citric acid, diethylhexyl sodium sulfosuccinate, carbomer, sodium hydroxide, hyaluronic acid, ethylhexylglycerin, morinda citrifolia extract, phenoxyethanol, dimethicone, sodium metabisulfite, peg-40 stearate, silica, sorbitan stearate, tocopherol

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 Do Not Use 15 words ▾

Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.

📄 When Using This Product 94 words ▾

When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid unnecessary sun exposure and use a sunscreen.

Avoid contact with the eyes, lips, and mouth. Avoid contact with hair and dyed fabrics, which may be bleached by this product. Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.

Irritation may be reduced by using the product less frequently or in a lower concentration.

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor If irritation becomes severe

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 3 words ▾

Questions 1-866-41-AVENE (28363)

📄 Package Label / Principal Display Panel 47 words ▾

Packaging EAU THERMALE AVENE LABORATORIE DERMATOLOGIQUE CLEANANCE ACNE MEDICATED CLEARING TREATMENT ACNE MEDICATED CREAM [BENZOYL PEROXIDE 5.5% FOR OILY, ACNE-PRONE, SENSITIVE SKIN REDUCES THE SEVERITY AND HELPS PREVENT NEW ACNE BLEMISHES, PIMPLES AND BLACKHEADS FROM FORMING 40 ML /

1.3FL.OZ. Avene Cleanance Acne Medicated Clearing Treatment

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epsolay. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Pierre Fabre USA 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 1 bottle (64760-0776-02). 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?
Pierre Fabre USA 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.
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.