Benzoyl Peroxide Acne Medication 50 mg/mL Gel, 42.5 mL — NDC 68071-2307-5 (Billing 68071-2307-05)
by NuCare Pharmaceuticals,Inc. · 42.5 mL in 1 TUBE
This is a package of 42.5 mL of Benzoyl Peroxide Acne Medication 50 mg/mL Gel from NuCare Pharmaceuticals,Inc., marketed since Jan 2015 and currently FDA-listed. It is this product's only package size.
NDC 68071-2307-05
🏷️ FDA NDC (as labeled)
68071-2307-5
billing pads the package segment with a zero
🗂️ 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)
68071-2307-5
Product NDC
68071-2307
11-digit billing NDC
68071230705
RxCUI
308694
UNII
W9WZN9A0GM
UPC
0368071230758
Application #
M014
SPL Set ID
b55acec6-5a4d-08b7-e053-2995a90a0f74
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2015-01-20
Route
TOPICAL
Dosage form
GEL
Substance
BENZOYL PEROXIDE
Quick answers
- RxCUI (RxNorm): 308694
Why two NDCs?
The FDA registers this code as 68071-2307-5 — 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 → 68071-2307-05. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📗 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.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Benzoyl Peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68071-2307-05 You're viewing this Main listing | 42.5 mL in 1 TUBE | 2020-11-30 | — | Active |
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 | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1057-75 | Rugby | 1 tube | $0.067 | — | Discontinued | — |
| benzoyl peroxide 5 g/100g 45802-0216-01 | Padagis | 1 tube | $0.178 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1055-25 | Rugby | 1 tube | $0.218 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/g 00536-1467-25 | Rugby | 1 tube | $0.218 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 50090-1720-00 | A-S | 1 tube | — | — | FDA listed | — |
| Replenix Acne 50 mg/g 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/mLthis 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 | — |
| ACNE FORTE Acne Treatment Cream 50 mg/mL 52063-0709-00 | GSCM | 1 jar | — | — | FDA listed | — |
| SERIOUS SKINCARE Continuously Clear Clearz It 50 mg/mL 53755-0392-00 | Flageoli | 59 ml | — | — | FDA listed | — |
| Acne Treatment 50 mg/mL 67226-2050-03 | Vivier | 1 tube | — | — | FDA listed | — |
| MD-Acne Body Acne Treatment 50 mg/mL 71804-0230-06 | MD | 180 ml | — | — | FDA listed | — |
| Nighttime Control 50 mg/mL 76458-0333-02 | Circadia | 1 bottle | — | — | FDA listed | — |
| 5 Percent Benzoyl Peroxide Cleanser 50 mg/mL 81136-0023-01 | Brand | 1 tube | — | — | FDA listed | — |
| Walgreens Daily Acne Cleanser- Sensitive Skin Formula 50 mg/mL 00363-5602-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| MDacne Customized Acne Treatment Benzoyl Peroxide 50 mg/mL 71804-0536-00 | MDAlgorithms | 1 tube | — | — | FDA listed | — |
| MDacne Body Acne Treatment Benzoyl Peroxide 50 mg/mL 71804-0532-00 | MDAlgorithms | 90 ml | — | — | FDA listed | — |
| OXY Sensitive Face Wash Maximum Soothing 50 mg/mL 10742-1313-01 | The | 148 ml | — | — | FDA listed | — |
| Clenziderm Therapeutic 50 mg/mL 62032-0611-01 | Obagi | 47 ml | — | — | FDA listed | — |
| Face Reality 5% Advanced Acne Med 50 mg/mL 70707-0157-01 | Face | 1 tube | — | — | FDA listed | — |
| OXY Advanced Care Sensitive Skin Acne Cleanser 50 mg/mL 10742-1203-01 | The | 148 ml | — | — | FDA listed | — |
| Naturium Benzoyl Peroxide Cleanser 5% 50 mg/mL 76354-0123-01 | e.l.f. | 1 tube | — | — | FDA listed | — |
| BLAIR and JACK Anti-Bump Acne Treatment 50 mg/mL 84377-0489-00 | Blair | 1 jar | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Sep 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerNuCare Pharmaceuticals,Inc.
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code68071
First marketedJan 2015
Product typeHuman Otc Drug
Portfolio1,015 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 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 5% Purpose Acne treatment
🧪 Inactive Ingredients ▾
Inactive ingredients carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water
🎯 Purpose ▾
Purpose Acne treatment
📄 Do Not Use ▾
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
📄 When Using This Product ▾
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 ▾
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.
📄 Questions or Comments ▾
Questions or comments? 1-800-645-2158
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - PDP
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 ↗
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 Benzoyl Peroxide — the ingredient across all brands.
Top reported reactions
Reporter sex
Male · 23%
Female · 76%
Unknown · 0%
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.
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 | — 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) | — 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 NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NuCare Pharmaceuticals,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.
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.