Anti Bac Acne Clearing Benzoyl Peroxide 5 g/100mL Lotion, 50 mL
by Cosmetic Enterprise Ltd · 50 mL in 1 BOTTLE (56152-4012-1)
NDC 56152-4012-01
🏷️ FDA NDC (as labeled)
56152-4012-1
billing pads the package segment with a zero
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)
56152-4012-1
Product NDC
56152-4012
11-digit billing NDC
56152401201
UNII
W9WZN9A0GM
Application #
M006
SPL Set ID
7f6ee76b-c664-2ec4-e053-2991aa0a9488
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-01-14
Route
TOPICAL
Dosage form
LOTION
Substance
BENZOYL PEROXIDE
Why two NDCs?
The FDA registers this code as 56152-4012-1 — a 5-4-1 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 package segment → 56152-4012-01. 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.
🏷️ 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
LabelerCosmetic Enterprise Ltd
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code56152
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio2 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
📗 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.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 | 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.
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 Acne Medication 50 mg/mL 00536-1057-75 | Rugby | 1 tube | $0.067 | — | Discontinued | — |
| Oxy 5 Vanishing 50 mg/g 10742-8355-01 | The | 1 bottle | — | — | FDA listed | — |
| Oxy 5 Tinted 50 mg/g 10742-8356-01 | The | 1 bottle | — | — | FDA listed | — |
| Anti Bac Acne Clearing 5 g/100mLthis 56152-4012-01 | Cosmetic | 50 ml | — | — | FDA listed | — |
| Clenziderm Therapeutic 50 mg/mL 62032-0611-01 | Obagi | 47 ml | — | — | FDA listed | — |
| Clear Cell Clarifying Acne 50 mg/g 62742-4208-01 | Allure | 7 g | — | — | FDA listed | — |
| Clear Med 5% 5 g/100mL 70764-0106-51 | CONTROL | 1 tube | — | — | FDA listed | — |
| Acne Control Serum 5 g/100g 72957-0001-01 | Private | 32 g | — | — | FDA listed | — |
| Nighttime Control 50 mg/mL 76458-0333-02 | Circadia | 1 bottle | — | — | FDA listed | — |
| Bubble Fade Away Acne Spot Treatment 50 mg/mL 83509-0003-01 | BUBBLE | 1 tube | — | — | FDA listed | — |
| Monat Acne Treatment 5 g/100mL 78518-0295-01 | Monat | 15 ml | — | — | FDA listed | — |
| PCA SKIN BPO Cleanser 5 g/100mL 68726-0168-04 | CP | 1 bottle | — | — | FDA listed | — |
| Breakout Control Bioelements 5 g/100mL 56152-4009-02 | Cosmetic | 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
🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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.
📊 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 56152-4012-01 You're viewing this | 50 mL in 1 BOTTLE (56152-4012-1) | 2019-01-14 | Active |
🧭 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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 FDA registers it as 56152-4012-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 56152-4012-01, written without dashes as 56152401201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 56152-4012-01, the first segment (56152) is the labeler code FDA assigned to Cosmetic Enterprise Ltd; the middle segment (4012) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Cosmetic Enterprise Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosmetic Enterprise Ltd 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.
📄 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
🎯 Indications and Usage ▾
Stop use and ask a doctor if irritation becomes severe.
⏱️ Dosage and Administration ▾
Directions Clease Skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 days. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor 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 products and ask a doctor.
⚠️ Warnings ▾
Warnings For external use only When using this product Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not use this product if you have very sensitive skin or if you are sensitive to Benzoyl Peroxide.
Avoid unnecesary 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 possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
🧪 Active Ingredient ▾
Active Ingredient Benzoyl Peroxide 5% Purpose Acne Treatment
🧪 Inactive Ingredients ▾
Inactive Ingredients Water/Aqua/Eau, PPG-2 Myristyl Ether Propionate, Argania Spinosa Kernel Extract, PEG-40 Sterate, Serenoa Serrulata Fruit Extract, Sesamum Indicum (sesame) Seed Extract, Alcohol Denat., Sorbitan Stearate, Hydrogenated Methyl Abeitate, Methyl Methacrylate Crosspolymer, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Tetrasodium EDTA, Hydrogenated Lecithin, Cholesterol, Ceramide NS, Ceramide NP, Oleic Acid, Plamitic Acid, Sodium Ascorbate, Sodium Hydroxide, EDTA, Ethylhexylglycerin, Phenoxyethanol
🎯 Purpose ▾
Use For the treatment of acne Helps keep skin clear of new acne blemishes
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.