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Rugby Benzoyl Peroxide Acne Medication 100 mg/g Gel — NDC 00536-1459-25 package photo

Rugby Benzoyl Peroxide Acne Medication 100 mg/g Gel

by Rugby Laboratories · 1 TUBE in 1 CARTON (0536-1459-25) / 60 g in 1 TUBE
NDC 00536-1459-25
🏷️ FDA NDC (as labeled) 0536-1459-25 billing pads the labeler 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 0536-1459-25
Product NDC 0536-1459
11-digit billing NDC 00536145925
NCPDP billing unit GM — per gram (weight)
RxCUI 486131
UNII W9WZN9A0GM
Application # M006
SPL Set ID 1ac05b1f-d508-4e9b-bef1-22e522ad740f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-31
Route TOPICAL
Dosage form GEL
Substance BENZOYL PEROXIDE
GPI-14 90050010004015
GCN Seq No 005810
GCN 22930
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 10% GEL
FDB brand name Benzoyl Peroxide
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1459-25 — 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 → 00536-1459-25. 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

LabelerRugby Laboratories
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio149 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 10% GEL 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?
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzoyl Peroxide (3 interactions) — ranked by severity →
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.

💊 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 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 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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.

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

The official label also statescarbomer, disodium EDTA, glycerin, sodium hydroxide, titanium dioxide, water.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.232 $13.89 / 60 g
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.
NADAC price history (per g) — tap or hover for the price & month
Jul 2026 Aug 2026 Sep 2026 $0.239 $0.232
▼ Down 3% over the last 3 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 Rugby 237 g $0.047 — Availability likely save 80%
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 Rugby 237 g $0.047 — Discontinued save 80%
benzoyl peroxide 10 g/100g 45802-0308-01 Padagis 1 tube $0.181 — Availability likely save 22%
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1056-25 Rugby 1 tube $0.231 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/gthis 00536-1459-25 Rugby 1 tube $0.231 — Availability likely —
PanOxyl Acne Clearing Spot Treatment 100 mg/g 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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 NDCDescription Marketing startStatus
00536-1459-25 You're viewing this 1 TUBE in 1 CARTON (0536-1459-25) / 60 g in 1 TUBE 2025-10-31 Active

📄 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 6 words ▾

Use for the treatment of acne

⏱️ Dosage and Administration 92 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 sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 154 words ▾

Warnings For external use only Do not use this medication 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 consult a doctor if irritation becomes severe If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

📦 Storage and Handling 9 words ▾

Other information Keep tightly closed Store at room temperature

🧪 Active Ingredient 9 words ▾

Active ingredient Benzoyl peroxide USP 10% Purpose Acne medication

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients carbomer, disodium EDTA, glycerin, sodium hydroxide, titanium dioxide, water.

🎯 Purpose 3 words ▾

Purpose Acne medication

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1457-69 · Rugby 00536-1466-25 · Rugby →
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.