Zapzyt Acne Treatment Gel Benzoyl Peroxide 10 g/100g Gel
by Focus Consumer Healthcare, LLC · 1 TUBE in 1 CARTON (71687-0011-1) / 28 g in 1 TUBE
NDC 71687-0011-01
🏷️ FDA NDC (as labeled)
71687-0011-1
billing pads the package 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 →
🚨
Active recall for this product.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
71687-0011-1
Product NDC
71687-0011
11-digit billing NDC
71687001101
RxCUI
486131
UNII
W9WZN9A0GM
UPC
0010768001102
Application #
M006
SPL Set ID
6079d45c-dd86-6f2e-e053-2991aa0a9743
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-12-16
Route
TOPICAL
Dosage form
GEL
Substance
BENZOYL PEROXIDE
Why two NDCs?
The FDA registers this code as 71687-0011-1 — 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 → 71687-0011-01. 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.
🏭 Manufacturer & labeler
LabelerFocus Consumer Healthcare, LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code71687
First marketedDec 2017
Product typeHuman Otc Drug
Portfolio11 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 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 0W44HYL8T5
A mild alkaline chemical compound used as a pH adjuster and emulsifier in medicines. It helps neutralize acidity and allows oil and water-based ingredients to mix smoothly in liquid formulations.
-
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 6HQ855798J
Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
-
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 statesLaureth-4, Carbomer, Disodium EDTA, Dilsopropanolamine, Purified Water USP
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 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/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/100gthis 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 | — |
| Modesa Acne Treatment 10 g/100g 55621-0017-01 | Zhejiang | 1 tube | — | — | FDA listed | — |
| Clearasil Rapid Rescue Spot Treatment 10 g/100g 63824-0433-01 | Reckitt | 1 tube | — | — | FDA listed | — |
| Age Intervention Duality Md 10 g/100g 65113-2373-02 | G.S. | 28 g | — | — | FDA listed | — |
| Age Intervention Duality 10 g/100g 65113-2372-02 | G.S. | 28 g | — | — | FDA listed | — |
| Clearasil Stubborn Acne Control 5in1 Spot Treatment 10 g/100g 63824-0438-01 | Reckitt | 1 tube | — | — | FDA listed | — |
| Dermaharmony 10% Benzoyl Peroxide Cleansing Bar 10 g/100g 71819-0011-04 | D3 | 113 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
🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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 Zapzyt Acne Treatment Gel (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 40%
Female · 60%
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 |
|---|---|---|---|
| 71687-0011-01 You're viewing this | 1 TUBE in 1 CARTON (71687-0011-1) / 28 g in 1 TUBE | 2017-12-16 | 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 71687-0011-1, 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: 71687-0011-01, written without dashes as 71687001101. 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 71687-0011-01, the first segment (71687) is the labeler code FDA assigned to Focus Consumer Healthcare, LLC; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Focus Consumer Healthcare, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Focus Consumer Healthcare, LLC 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 for the treatment and prevention of acne pimples, blemishes, blackheads or whiteheads
⏱️ Dosage and Administration ▾
Directions Use a ZAPZYT cleaning product to thoroughly wash face before applying gel. Apply ZAPZYT Acne Treatment Gel to areas where pimples and excess oil occur Apply ZAPZYT before using moisturizer or makeup; do not rinse. If excessive drying of the skin occurs, reduce applications to once a day, or every other day. For best results use up to three tiimes daily. Once your skin has cleared, continue using ZAPZYT to keep new pimples from forming
⚠️ Warnings ▾
Warnings For external use only.
🧪 Active Ingredient ▾
Active ingredient Benzoyl Peroxide 10%
🧪 Inactive Ingredients ▾
Inactive ingredients Laureth-4, Carbomer, Disodium EDTA, Dilsopropanolamine, Purified Water USP
🎯 Purpose ▾
Purpose Acne treatment
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.