Replenix Acne Benzoyl Peroxide 50 mg/g Gel, 57 g
by Topiderm, Inc · 57 g in 1 TUBE (51326-411-57)
NDC 51326-0411-57
🏷️ FDA NDC (as labeled)
51326-411-57
billing pads the product 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)
51326-411-57
Product NDC
51326-411
11-digit billing NDC
51326041157
RxCUI
308694
UNII
W9WZN9A0GM
Application #
M006
SPL Set ID
03d4c298-8f44-41f7-b086-96ae836152bb
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1993-01-22
Route
TOPICAL
Dosage form
GEL
Substance
BENZOYL PEROXIDE
Why two NDCs?
The FDA registers this code as 51326-411-57 — a 5-3-2 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 product segment → 51326-0411-57. 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
LabelerTopiderm, Inc
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code51326
First marketedJan 1993
Product typeHuman Otc Drug
Portfolio6 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
📖 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.
💡 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 DIG6BWZ9XT
Sodium hydroxymethylglycinate is a preservative that prevents bacterial and fungal growth in liquid medicines and personal care products. It works by releasing formaldehyde in small amounts to keep the product stable and safe during storage.
-
UNII 632GS99618
Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCarbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.
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 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 |
|---|---|---|---|---|---|---|
| benzoyl peroxide 5 g/100g 45802-0216-01 | Padagis | 1 tube | $0.179 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1055-25 | Rugby | 1 tube | $0.217 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/g 00536-1467-25 | Rugby | 1 tube | $0.217 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 50090-1720-00 | A-S | 1 tube | — | — | FDA listed | — |
| Replenix Acne 50 mg/gthis 51326-0411-57 | Topiderm, | 57 g | — | — | FDA listed | — |
| Clear Proof Acne Treatment Acne Medication 5 g/100g 51531-9071-00 | Mary | 3 g | — | — | FDA listed | — |
| Benzoyl Peroxide Acne Medication 50 mg/mL 68071-2307-05 | NuCare | 42.5 ml | — | — | FDA listed | — |
| 5 Acne Med 50 mg/mL 70707-0155-15 | Face | 1 tube | — | — | Discontinued | — |
| Acne Med 5% 50 mg/mL 70707-0211-15 | Face | 1 bottle | — | — | FDA listed | — |
| MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 50 mg/mL 71399-9478-05 | Akron | 1 tube | — | — | FDA listed | — |
| HUMANE Acne Spot Treatment 50 mg/mL 73010-0127-00 | Apprendista, | 1 tube | — | — | FDA listed | — |
| 24 Hour Acne Serum 5 g/100g 83286-0007-01 | Drmtlgy, | 32 g | — | — | FDA listed | — |
| Glytone Acne BPO Treatment Gel .05 g/g 84262-0030-01 | Glytone, | 60 g | — | — | FDA listed | — |
| Epsolay 50 mg/g 00299-5890-00 | Galderma | 3 g | — | — | Discontinued | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/g 75376-0467-25 | Guangzhou | 1 tube | — | — | FDA listed | — |
| 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 | — |
| Clear Cell Clarifying Acne 50 mg/g 62742-4208-01 | Allure | 7 g | — | — | 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
🏛️
1993
On the market since
Jan 1993
📍
2026
Currently FDA-listed
33 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Replenix Acne (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 40%
Female · 59%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51326-0411-57 You're viewing this | 57 g in 1 TUBE (51326-411-57) | 1993-01-22 | 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 | ✓ 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 FDA registers it as 51326-411-57, 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: 51326-0411-57, written without dashes as 51326041157. 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 51326-0411-57, the first segment (51326) is the labeler code FDA assigned to Topiderm, Inc; the middle segment (0411) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (57) 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 Topiderm, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topiderm, 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 ▾
Uses Topical acne medication.
⏱️ Dosage and Administration ▾
Directions Cleanse the skin thoroughly before applying. Apply a thin layer daily, then gradually increase to two or three times daily. If bothersome drying or peeling occurs, reduce applications. If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
⚠️ Warnings ▾
Warnings When using this product avoid unnecessary sun exposure and use a sunscreen. For external use only. Keep away from eyes, lips, and mouth.
If irritation develops, discontinue use and consult a doctor. 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, consult a doctor.
May bleach fabrics. Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
🧪 Active Ingredient ▾
Active ingredient Benzoyl Peroxide, USP 5%
🧪 Inactive Ingredients ▾
Inactive ingredients Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.
🎯 Purpose ▾
Purpose Anti-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.