Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg Paste, 1 tube
by Cosco International, Inc. · 1 TUBE in 1 CARTON (52261-7301-1) / .0618 kg in 1 TUBE
NDC 52261-7301-01
🏷️ FDA NDC (as labeled)
52261-7301-1
billing pads the package segment with a zero
This package
Contains1 tube
Pack sizes2 compare ↓
Also comes in:
1 tube 52261-7301-02
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)
52261-7301-1
Product NDC
52261-7301
11-digit billing NDC
52261730101
RxCUI
308696
UNII
W9WZN9A0GM
Application #
M006
SPL Set ID
464c0ed1-ebc4-45b1-80e3-dfe0b76312e3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-11-11
Route
TOPICAL
Dosage form
PASTE
Substance
BENZOYL PEROXIDE
Why two NDCs?
The FDA registers this code as 52261-7301-1 — 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 → 52261-7301-01. 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
LabelerCosco International, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code52261
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio24 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.
Try another pack size:
1 tube
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 | — |
| Benzoyl Peroxide 50 mg/mL 35573-0453-08 | Burel | 237 ml | $0.046 | — | Availability likely | — |
| benzoyl peroxide 5 g/100g 45802-0280-01 | Padagis | 142 g | $0.052 | — | Discontinued | — |
| 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/kgthis 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 | — |
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
🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 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 |
|---|---|---|---|
| 52261-7301-01 You're viewing this | 1 TUBE in 1 CARTON (52261-7301-1) / .0618 kg in 1 TUBE | 2024-11-11 | Active |
| 52261-7301-02 | 1 TUBE in 1 CARTON (52261-7301-2) / .0313 kg in 1 TUBE | 2026-03-17 | Active |
Pack size FAQ
What quantity is in NDC 52261-7301-01?
NDC 52261-7301-01 contains 1 tube — 1 tube in 1 carton / .0618 kg in 1 tube.
What is the difference between NDC 52261-7301-01 and NDC 52261-7301-02?
Both are Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg Paste — the drug itself is identical. NDC 52261-7301-01 is the 1 tube package, while NDC 52261-7301-02 is the 1 tube package.
What NDC number is used to bill for this package of Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg Paste?
Bill NDC 52261-7301-01 — the 11-digit billing format is 52261730101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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) | — 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 52261-7301-1, 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: 52261-7301-01, written without dashes as 52261730101. 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 52261-7301-01, the first segment (52261) is the labeler code FDA assigned to Cosco International, Inc.; the middle segment (7301) 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 Cosco International, 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 tube (52261-7301-02). 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?
Cosco International, 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.
📄 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 ▾
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.
⏱️ Dosage and Administration ▾
Directions Clean the skin throughly before applying this product Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly. Use once a day or as directed by a doctor. If dryness or peeling occurs, reduce application to once every other day. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use and consult a doctor.
⚠️ Warnings ▾
Warnings For external use only Do not use if you have very sensitive skin are sensitive to benzoyl peroxide Ask doctor before use if you have redness over the affected area 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 ▾
Active Ingredient/Purpose Benzoyl Peroxide............Acne Treatment
🧪 Inactive Ingredients ▾
Inactive Ingredients Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Glycolic Acid, Niacinamide, Panthenol, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethylcellulose, Carbomer, Xanthan Gum, Tocopheryl Acetate, Sodium Hydroxide, Sodium Citrate, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Silica, Sorbitan Stearate, PEG-40 Stearate
🎯 Purpose ▾
Use For the treatment of acne
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.