Rugby Benzoyl Peroxide Acne Medication 100 mg/mL Lotion, 1 tube
by Rugby Laboratories · 1 TUBE in 1 CARTON (0536-1058-75) / 29.5 mL in 1 TUBE
NDC 00536-1058-75
🏷️ FDA NDC (as labeled)
0536-1058-75
billing pads the labeler segment with a zero
OTC
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ 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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
0536-1058-75
Product NDC
0536-1058
11-digit billing NDC
00536105875
NCPDP billing unit
ML — per mL (volume)
RxCUI
106310
UNII
W9WZN9A0GM
Application #
M006
SPL Set ID
460095b7-0e93-4179-877b-cc5f1b39fa0d
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Aug 2026)
Marketing start
2015-01-20
Marketing end
2026-08-01
Route
TOPICAL
Dosage form
LOTION
Substance
BENZOYL PEROXIDE
GPI-14
90050010004120
GPI class
Acne Medication 10
GCN Seq No
005817
GCN
28610
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
ACNE MEDICATION 10% LOTION
FDB brand name
Acne Medication
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0536-1058-75 — 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 → 00536-1058-75. 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 marketedJan 2015
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 ACNE MEDICATION 10% LOTION 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.
🧪 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.074 | $2.18 / 29.5 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1940 | $5.72 / 29.5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 6% over the last 2 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 100 mg/mL 00536-1261-63 | Rugby | 148 ml | $0.047 | — | Availability likely | save 36% |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/mLthis 00536-1058-75 | Rugby | 1 tube | $0.074 | — | Discontinued | — |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1056-25 | Rugby | 1 tube | $0.239 | — | Discontinued | +222% |
| 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 | — |
| CVS Health Acne Control Cleanser Acne Medication 100 mg/g 69842-0571-02 | CVS | 141 g | — | — | FDA listed | — |
| Clear Med 10% 10 g/100mL 70764-0107-51 | CONTROL | 1 tube | — | — | FDA listed | — |
| BP Acne Spot Treatment 100 mg/g 73318-7002-05 | Skin | 1 bottle | — | — | FDA listed | — |
| CeraVe Acne Foaming CreamWash 100 mg/mL 49967-0604-01 | L'Oreal | 1 tube | — | — | Discontinued | — |
| Acne Med 10% 100 mg/mL 70707-0212-15 | Face | 1 bottle | — | — | FDA listed | — |
| OXY 10 Acne Cleanser 100 mg/mL 10742-1397-01 | The | 148 ml | — | — | FDA listed | — |
| Terminator 10 100 mg/mL 80861-0002-01 | AcneFree, | 1 tube | — | — | FDA listed | — |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 50090-1792-00 | A-S | 1 tube | — | — | FDA listed | — |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 68071-4393-01 | NuCare | 42.5 ml | — | — | FDA listed | — |
| ZO Skin Health Acne Control Benzoyl Peroxide 100 mg/mL 42851-0087-60 | ZO | 1 tube | — | — | FDA listed | — |
| 10 Acne Med 100 mg/mL 70707-0151-15 | Face | 1 tube | — | — | FDA listed | — |
| Face Reality 10% Advanced Acne Med 100 mg/mL 70707-0158-01 | Face | 1 tube | — | — | FDA listed | — |
| MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL 71399-9474-05 | Akron | 1 tube | — | — | FDA listed | — |
| OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/mL 10742-1202-01 | The | 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
🏛️
2015
On the market since
Jan 2015
📍
2026
Currently FDA-listed
11 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 00536-1058-75, 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
1.3K
Units reimbursed last 4 qtrs
51.3K
Gross reimbursed last 4 qtrs
$10K
Avg / prescription
$7.60
Avg / unit
$0.1940
Latest quarter Q4 2025
140Rx
Medicaid pays / mL
$0.1940
gross reimbursed
vs
NADAC / mL
$0.0740
acquisition cost
=
Spread
+$0.1200
+162% vs cost
What Medicaid paid per mL (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 · 619 Rx Managed care · 691 Rx
State Medicaid map
Units reimbursed · per 100k residents
7.6294
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.
📊 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 |
|---|---|---|---|
| 00536-1058-75 You're viewing this | 1 TUBE in 1 CARTON (0536-1058-75) / 29.5 mL in 1 TUBE | 2015-01-20 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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) | ✓ Available |
| 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) | ✓ Available |
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0536-1058-75, 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: 00536-1058-75, written without dashes as 00536105875. 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 00536-1058-75, the first segment (00536) is the labeler code FDA assigned to Rugby Laboratories; the middle segment (1058) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (75) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Rugby 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.
📄 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 Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.
⚠️ Warnings ▾
Warnings For external use only Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide. When using this product n keep away from eyes, lips and mouth avoid unnecessary sun exposure and use a sunscreen avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor. using other topical acne medication at the same time or immediately following the 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. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.
📦 Storage and Handling ▾
Other information Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).
🧪 Active Ingredient ▾
Active ingredient Benzoyl peroxide 10%
🧪 Inactive Ingredients ▾
Inactive ingredients carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water
🎯 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.