Benzoyl Peroxide 50 mg/mL Liquid, 237 mL
by Burel Pharmaceuticals, LLC · 237 mL in 1 BOTTLE (35573-453-08)
NDC 35573-0453-08
🏷️ FDA NDC (as labeled)
35573-453-08
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.0528/unit — full pricing hub ↓
Also comes in:
148 ml 35573-0453-91
OTC
On market
Non-controlled
🗂️ Data synced 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
FDA NDC (as labeled)
35573-453-08
Product NDC
35573-453
11-digit billing NDC
35573045308
NCPDP billing unit
GM — per gram (weight)
UNII
W9WZN9A0GM
UPC
0335573454081, 0335573454913
Application #
M006
SPL Set ID
0617d42d-511d-4c1a-a919-b37abbc14efc
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-04-15
Route
TOPICAL
Dosage form
LIQUID
Substance
BENZOYL PEROXIDE
GPI-14
90050010000905
GPI class
Benzoyl Peroxide Wash
GCN Seq No
063965
GCN
99676
HICL code
002470
Ingredient (HICL)
Benzoyl Peroxide
HIC1 code
L
Therapeutic class — broad (HIC1)
Skin/Subcutaneous Tissue
HIC2 code
L5
Therapeutic class — intermediate (HIC2)
Keratolytics/Keratoplastics
HIC3 code
L5A
Therapeutic class — specific (HIC3)
Keratolytics
AHFS code
84:28.00.00
AHFS class
Keratolytic Agents
FDB label name
BENZOYL PEROXIDE 5% WASH
FDB brand name
Benzoyl Peroxide
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 35573-453-08 — 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 → 35573-0453-08. 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.
🏷️ RxNorm drug class
This medicine belongs to the Peroxides class.
Drug family (ATC)
Peroxides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerBurel Pharmaceuticals, LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code35573
First marketedApr 2022
Product typeHuman Otc Drug
Portfolio29 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.
🩺 Clinical
Label name BENZOYL PEROXIDE 5% WASH Ingredient Benzoyl Peroxide
📖 What it is MedlinePlus · NLM
Benzoyl peroxide is used to treat mild to moderate acne.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Most benzoyl peroxide products are used to treat acne — they clear up pimples, blemishes, blackheads, and whiteheads, and help keep new ones from forming. One prescription product,...
- What exactly is benzoyl peroxide used for?
- Yes, some dryness, redness, peeling, and mild irritation are very common, especially when you first start. The best strategy is to begin with just once daily and slowly work up to...
- My skin got really dry and red after I started using it — is that normal?
Patient education
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.
💬 Questions about Benzoyl Peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 59TL3WG5CO
A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
-
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 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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 RD25J5V947
A waxy mixture derived from vegetable oils and polyethylene glycol that helps emulsify and blend oil-based and water-based ingredients. It's used in creams and lotions to create a smooth, uniform texture and improve product stability.
-
UNII OAH19558U1
A synthetic compound made from coconut oil, laureth-12 helps mix oil and water-based ingredients together. It acts as an emulsifier and surfactant in formulations, improving how the medicine spreads and is absorbed.
-
UNII 6M3P64V0NC
A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 3599J29ANH
A cleansing agent derived from coconut oil. It helps break down and mix oil and water in the formulation, and may aid in dispersing the active ingredient throughout the product.
-
UNII SLK428451L
Sodium lauroamphoacetate is a mild cleaning agent derived from coconut oil. It acts as a surfactant and emulsifier in medicines, helping blend water and oil-based ingredients together and improving how the product spreads or dissolves.
-
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.
12 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCarbomer interpolymer type A NF, cetyl alcohol NF, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.
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.
💲 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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.046 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.0528 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▼ Down 3% over the last 18 months.
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Benzoyl Peroxide Wash Acne Medication 50 mg/mL 00536-1259-19 | Rugby | 236 ml | $0.028 | — | Availability likely | save 38% |
| Benzoyl Peroxide 50 mg/mLthis 35573-0453-08 | Burel | 237 ml | $0.046 | — | Availability likely | — |
| benzoyl peroxide 5 g/100g 45802-0280-01 | Padagis | 142 g | $0.052 | — | Discontinued | +15% |
| Differin Daily Deep Cleanser with BPO 5 g/100mL 00299-4606-00 | Galderma | 1 tube | — | — | FDA listed | — |
| Walgreens Daily Acne Cleanser- Sensitive Skin Formula 50 mg/mL 00363-5602-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Oxy Sensitive Skin Acne Cream Cleanser 50 mg/mL 10742-1004-01 | The | 148 ml | — | — | FDA listed | — |
| OXY Advanced Care Sensitive Skin Acne Cleanser 50 mg/mL 10742-1203-01 | The | 148 ml | — | — | FDA listed | — |
| OXY Sensitive Face Wash Maximum Soothing 50 mg/mL 10742-1313-01 | The | 148 ml | — | — | FDA listed | — |
| SPOTLESS Daily Acne Wash .05 g/mL 14222-1610-01 | Rodan | 1 tube | — | — | FDA listed | — |
| BP Wash 50 mg/g 24470-0900-04 | CINTEX | 113 g | — | — | FDA listed | — |
| REPLENIX ACNE Solution BENZOYL PEROXIDE WASH 50 mg/mL 51326-0111-01 | Topiderm, | 200 ml | — | — | FDA listed | — |
| Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7300-01 | Cosco | 1 tube | — | — | FDA listed | — |
| Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7301-01 | Cosco | 1 tube | — | — | FDA listed | — |
| PCA SKIN BPO Cleanser 5 g/100mL 68726-0168-04 | CP | 1 bottle | — | — | FDA listed | — |
| HUMANE Acne Wash 5 50 mg/mL 69919-0526-08 | Banner | 1 bottle | — | — | FDA listed | — |
| MEDPURA Benzoyl Peroxide 50 mg/mL 71399-9234-05 | Akron | 148 ml | — | — | FDA listed | — |
| benzoyl peroxide 5 g/100g 72162-2338-02 | Bryant | 142 g | — | — | FDA listed | — |
| BP Body Wash 50 mg/g 73318-7005-01 | Skin | 1 tube | — | — | FDA listed | — |
| Naturium Benzoyl Peroxide Cleanser 5% 50 mg/mL 76354-0123-01 | e.l.f. | 1 tube | — | — | FDA listed | — |
| 5 Percent Benzoyl Peroxide Cleanser 50 mg/mL 81136-0023-01 | Brand | 1 tube | — | — | FDA listed | — |
| BENZOYL PEROXIDE 5% Topical wash 50 mg/mL 82461-0312-05 | Medcore | 148 ml | — | — | FDA listed | — |
| SkinPharmacy Advanced Acne Therapy Spot Treatment 50 mg/mL 69842-0023-01 | CVS | 1 tube | — | — | FDA listed | — |
| Dr. Zenovia Spot Treatment 50 mg/mL 51326-0802-01 | Topiderm, | 1 bottle | — | — | FDA listed | — |
| Bubble Fade Away Acne Spot Treatment 50 mg/mL 83509-0003-01 | BUBBLE | 1 tube | — | — | 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
🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 35573-0453-08, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
56.8K
Units reimbursed last 4 qtrs
13.4M
Gross reimbursed last 4 qtrs
$705.6K
Avg / prescription
$12.43
Avg / unit
$0.0528
Latest quarter Q4 2025
15.4KRx
Medicaid pays / g
$0.0528
gross reimbursed
vs
NADAC / g
$0.0456
acquisition cost
=
Spread
+$0.0072
+16% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 5,899 Rx Managed care · 50,887 Rx
State Medicaid map
Units reimbursed · per 100k residents
14626,910
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 115,101 Rx · 22,223,999 units · $1,331,819 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 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.
🔬 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 BENZOYL PEROXIDE — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 23%
Female · 76%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 35573-0453-08 You're viewing this | 237 mL in 1 BOTTLE (35573-453-08) | $0.0456 / g | — | 2022-04-15 | Active |
| 35573-0453-91 | 148 mL in 1 BOTTLE (35573-453-91) | $0.0496 / g | — | 2022-04-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0456 NADAC).
This pack accounts for about 49% of this product's recent Medicaid fills; most go to the 148 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 35573-0453-08?
NDC 35573-0453-08 contains 237 mL — 237 ml in 1 bottle.
What is the difference between NDC 35573-0453-08 and NDC 35573-0453-91?
Both are Benzoyl Peroxide 50 mg/mL Liquid — the drug itself is identical. NDC 35573-0453-08 is the 237 mL package, while NDC 35573-0453-91 is the 148 ml package. Per-g NADAC also differs: $0.0456 here vs $0.0496 for the 148 ml pack.
What NDC number is used to bill for this package of Benzoyl Peroxide 50 mg/mL Liquid?
Bill NDC 35573-0453-08 — the 11-digit billing format is 35573045308. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use For the treatment of acne
⏱️ Dosage and Administration ▾
Directions SHAKE WELL. Clean the skin thoroughly before applying this product. Sensitivity Test for a New User.
Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs,follow the directions stated below. One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed.
Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if 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. Follow directions in the sunscreen labeling. If irritation or sensitivity develops stop use of both products and ask a doctor.
⚠️ Warnings ▾
Warnings: For external use only. Avoid contact with eyes, eyelids, lips and mucous membranes. Do not use if you have very sensitive skin are sensitive to benzoyl peroxide When using this product Avoid unnecessary sun exposure and use a sunscreen.
Avoid contact with eyes, lips, and mouth. Avoid contact with hair or 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. 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.
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.
📦 Storage and Handling ▾
Other information Store at controlled room temperature, 15° - 30°C (59° - 86°F)
🧪 Active Ingredient ▾
Active Ingredient benzoyl peroxide USP, 5% or 10%
🧪 Inactive Ingredients ▾
Inactive Ingredients Carbomer interpolymer type A NF, cetyl alcohol NF, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.
🎯 Purpose ▾
Purpose Acne medication
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.