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PanOxyl Acne Clearing Spot Treatment Benzoyl Peroxide 100 mg/g Gel — NDC 00316-0298-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PanOxyl Acne Clearing Spot Treatment Benzoyl Peroxide 100 mg/g Gel — NDC 0316-0298-01 (Billing 00316-0298-01)

by Crown Laboratories · 1 TUBE in 1 CARTON / 28 g in 1 TUBE

This is a package of PanOxyl Acne Clearing Spot Treatment Benzoyl Peroxide 100 mg/g Gel from Crown Laboratories, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 00316-0298-01
🏷️ FDA NDC (as labeled) 0316-0298-01 billing pads the labeler segment with a zero
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) 0316-0298-01
Product NDC 0316-0298
11-digit billing NDC 00316029801
NCPDP billing unit GM — per gram (weight)
RxCUI 486131
UNII W9WZN9A0GM
UPC 0303160298011
Application # M006
SPL Set ID 507150a0-9c20-4a2e-e063-6394a90ab9c7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-01
Route TOPICAL
Dosage form GEL
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 486131
Why two NDCs? The FDA registers this code as 0316-0298-01 — a 4-4-2 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 labeler segment → 00316-0298-01. 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.

Clinical

📖 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 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 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.
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
00316-0298-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2026-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 Rugby 237 g $0.047 — Availability likely —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 Rugby 237 g $0.047 — Discontinued —
benzoyl peroxide 10 g/100g 45802-0308-01 Padagis 1 tube $0.181 — Availability likely —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1056-25 Rugby 1 tube $0.231 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/g 00536-1459-25 Rugby 1 tube $0.231 — Availability likely —
PanOxyl Acne Clearing Spot Treatment 100 mg/gthis 00316-0298-01 Crown 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Gel 100 mg/g 00363-0266-51 WALGREEN 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Treatment Acne medication 100 mg/g 00363-8798-01 Walgreen 1 tube — — FDA listed —
Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1201-01 The 1 tube — — FDA listed —
Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1205-01 The 2 g — — FDA listed —
Target Up And Up Acne Medication 100 mg/g 11673-0088-17 TARGET 1 tube — — FDA listed —
Acne Treatment 100 mg/g 11822-7701-03 Rite 1 tube — — FDA listed —
Signature Care Acne Medication 100 mg/g 21130-0730-17 SAFEWAY, 1 tube — — FDA listed —
Acne Treatment 100 mg/g 30142-0877-10 The 1 tube — — FDA listed —
Meijer Acne Treatment Acne medication 100 mg/g 41250-0347-01 Meijer 1 tube — — FDA listed —
Acne Treatment 100 mg/g 49035-0229-10 Walmart 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 50090-1792-00 A-S 1 tube — — FDA listed —
Replenix Acne 100 mg/g 51326-0412-57 Topiderm, 57 g — — FDA listed —
Replenix BP Acne 100 mg/g 51326-0841-20 Topiderm, 57 g — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 68071-4393-01 NuCare 42.5 ml — — FDA listed —
Neutrogena Rapid Clear Stubborn Acne Spot 100 mg/g 69968-0043-01 Kenvue 1 tube — — FDA listed —
Clean and Clear Persa-Gel 10 100 mg/g 69968-0212-01 Kenvue 1 tube — — FDA listed —
Clean and Clear persa-gel 10 Maximum Strength 100 mg/g 69968-0720-01 Kenvue 1 tube — — FDA listed —
10 Acne Med 100 mg/mL 70707-0151-15 Face 1 tube — — FDA listed —
Acne Med 10% 100 mg/mL 70707-0212-15 Face 1 bottle — — FDA listed —
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL 71399-9474-05 Akron 1 tube — — FDA listed —
Zapzyt Acne Treatment Gel 10 g/100g 71687-0011-01 Focus 1 tube — — FDA listed —
Acne Treatment 100 mg/g 72288-0229-10 Amazon.com 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/g 75376-0459-25 Guangzhou 1 tube — — FDA listed —
Acne Treatment 100 mg/g 76162-0229-10 Topco 1 tube — — FDA listed —
111 Medco Benzoyl Peroxide 100 mg/g 72811-0137-11 111 113 g — — FDA listed —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 75376-0474-42 Guangzhou 237 g — — FDA listed —
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/g 10742-1206-01 The 3 g — — FDA listed —
Acne Cleanser 100 mg/g 41250-0264-56 Meijer, 141 g — — FDA listed —
Walgreens Acne Control Cleanser Acne Medication 100 mg/g 00363-3602-01 Walgreen 142 g — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 72288-0264-56 Amazon.com 141 g — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 76162-0264-28 Topco 141 g — — FDA listed —
Acne Cleanser 100 mg/g 49035-0264-56 Walmart, 141 g — — FDA listed —
PanOxyl 100 mg/g 00316-0228-01 Crown 1 tube — — Discontinued —
Walgreens Acne Foaming Wash Acne Medication 100 mg/g 00363-1522-01 Walgreen 156 g — — FDA listed —
CVS Health Acne Control Cleanser Acne Medication 100 mg/g 69842-0571-02 CVS 141 g — — FDA listed —
Meijer Maximum Strength Foaming Acne Face Wash Acne Medication 100 mg/g 79481-0022-01 Meijer 1 tube — — FDA listed —
Equate Acne Wash Acne medication 100 mg/g 79903-0061-01 Wal-Mart 1 tube — — FDA listed —
Caring mill Acne Treatment 100 mg/g 81522-0951-01 FSA 28 g — — FDA listed —
CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment 100 mg/g 51316-0047-16 CVS 1 tube — — FDA listed —
Walgreens Maximum Strength Tinted Acne Spot Treatment Cream 100 mg/g 00363-0256-51 WALGREEN 1 tube — — FDA listed —
OXY Rapid Spot Treatment Maximum Action 100 mg/g 10742-1301-01 The 1 tube — — FDA listed —
Dermaclear Spot Treatment 100 mg/g 62742-4075-04 Allure 1 bottle — — FDA listed —
Oxy 10 Vanishing 100 mg/g 10742-8353-01 The 1 bottle — — FDA listed —
Oxy 10 Tinted 100 mg/g 10742-8354-01 The 1 bottle — — FDA listed —
Meijer Invisible Acne Acne medication 100 mg/g 41250-0348-01 Meijer 1 tube — — FDA listed —
Zitfree Acne Treatment 100 mg/g 67234-0035-01 Natureplex, 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Treatment 100 mg/g 00363-1363-17 WALGREEN 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 K0H1405S9C
    A synthetic organic compound used as a solvent or carrier in pharmaceutical formulations. It helps dissolve or suspend active ingredients and improve the stability and consistency of the medicine.
  • UNII 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • 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 F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • 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 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 WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • 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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 9CO8OUL4TH
    A synthetic conditioning agent derived from behenic acid, a long-chain fatty substance. It helps soften hair and reduce static in shampoos and conditioners by coating the hair shaft.
  • UNII Q613OCQ44Y
    Isostearyl alcohol is a fatty alcohol derived from plant or petroleum sources. It acts as an emollient and thickener in formulations, helping to soften the product and improve texture and stability.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • 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 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in 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 states1,2-Hexanediol, 4-t-Butylcyclohexanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Bisabolol, Butyrospermum Parkii (Shea) Butter, Carbomer, Carbomer Homopolymer Type C, Citric Acid, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Isostearyl Alcohol, Niacinamide, PEG-40 Stearate, Pentylene Glycol, Propanediol, Silica, Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Stearate, Xanthan Gum

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

LabelerCrown Laboratories
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio43 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 6 words ▾

Use for the treatment of acne

⏱️ Dosage and Administration 93 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 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 a sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 152 words ▾

Warnings For external use only Do not use if you have very sensitive skin 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 irritaiton becomes severe If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 16 words ▾

Other Information store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not exceed 30°C (86°F).

🧪 Active Ingredient 5 words ▾

Active ingredient Benzoyl Peroxide 10%

🧪 Inactive Ingredients 58 words ▾

Inactive ingedients 1,2-Hexanediol, 4-t-Butylcyclohexanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Bisabolol, Butyrospermum Parkii (Shea) Butter, Carbomer, Carbomer Homopolymer Type C, Citric Acid, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Isostearyl Alcohol, Niacinamide, PEG-40 Stearate, Pentylene Glycol, Propanediol, Silica, Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Stearate, Xanthan Gum

🎯 Purpose 3 words ▾

Purpose Acne medication

📄 Do Not Use 14 words ▾

Do not use if you have very sensitive skin 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 irritaiton becomes severe

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a healthcare professional before use.

📄 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? call 1-833-279-6522

📄 Package Label / Principal Display Panel 109 words ▾

PanOxyl Acne Clearing Spot Treatment 1oz Tube PDP PanOxyl Acne Clearing Spot Treatment for Face 10% BENZOYL PEROXIDE ACNE TREATMENT GEL MAXIMUM STRENGTH Clears existing ance and helps prevent new breakouts DERMATOLOGIST RECOMMNENDED Net wt. 1 oz (28 g) Distributed by Crown Laboratories, Inc. Johnson City, TN P12714.00 1oz tube

PanOxyl Acne Clearing Spot Treatment 1oz Carton PanOxyl Acne Clearing Spot Treatment for Face 10% BENZOYL PEROXIDE ACNE TREATMENT GEL MAXIMUM STRENGTH Clears existing ance and helps prevent new breakouts Powerful, fast-acting maximum strength formula No. 1 DERMATOLOGIST RECOMMNENDED BENZOYL PEROXIDE BRAND Net wt. 1 oz (28 g) Distributed by Crown Laboratories, Inc. Johnson City, TN P12715.01 1oz carton

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 Crown Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Crown Laboratories 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.