Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL Gel, 1 tube — NDC 71399-9474-5 (Billing 71399-9474-05)
by Akron Pharma Inc. · 1 TUBE in 1 CARTON / 42.5 mL in 1 TUBE
This is a package of 1 tube of MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL Gel from Akron Pharma Inc., marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.
NDC 71399-9474-05
🏷️ FDA NDC (as labeled)
71399-9474-5
billing pads the package segment with a zero
This package
Contains1 tube
Pack sizes3 compare ↓
🗂️ FDA directory synced Oct 8, 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 →
NDC database record
One package, one record: these facts belong to NDC 71399-9474-5 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 71399 labeler · 9474 product · 5 package
- Package marketed since
- Sep 13, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0371399947857, 0371399947895, 0371399947499
- FDA record last changed
- Jul 24, 2026
⚠️
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)
71399-9474-5
Product NDC
71399-9474
11-digit billing NDC
71399947405
NCPDP billing unit
GM — per gram (weight)
UNII
W9WZN9A0GM
UPC
0371399947857, 0371399947895, 0371399947499
Application #
M006
SPL Set ID
b7d335d1-3022-4b28-913c-477152a7dad2
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-09-13
Route
TOPICAL
Dosage form
GEL
Substance
BENZOYL PEROXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90050010004015
GPI class
Medpura Benzoyl Peroxide
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
Quick answers
- GSN (GCN sequence number): 005810
- GCN: 22930
- GPI-14 (Medi-Span): 90050010004015
- HICL (First Databank): 002470
- AHFS class code: 84:28.00.00
- RxCUI (RxNorm): 308694
Why two NDCs?
The FDA registers this code as 71399-9474-5 — 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 → 71399-9474-05. 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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
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 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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
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 8, 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 |
|---|---|---|---|---|
| 71399-9474-05 You're viewing this Main listing | 1 TUBE in 1 CARTON / 42.5 mL in 1 TUBE | 2021-11-04 | — | Active |
| 71399-9474-06 71399-9474-6 | 1 TUBE in 1 CARTON / 60 mL in 1 TUBE | 2021-11-04 | — | Active |
| 71399-9474-09 71399-9474-9 | 1 TUBE in 1 CARTON / 90 mL in 1 TUBE | 2023-01-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 42.5 ml in 1 tube.
What NDC number is used to bill for this package of MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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 | — |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1058-75 | Rugby | 1 tube | $0.074 | — | Discontinued | — |
| 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/mLthis 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 | — |
| CeraVe Acne Foaming CreamWash 100 mg/mL 49967-0604-01 | L'Oreal | 1 tube | — | — | Discontinued | — |
| 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 | — |
| ZO Skin Health Acne Control Benzoyl Peroxide 100 mg/mL 42851-0087-60 | ZO | 1 tube | — | — | FDA listed | — |
| Face Reality 10% Advanced Acne Med 100 mg/mL 70707-0158-01 | Face | 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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 Oct 3, 2026
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.
- FDA label on DailyMed · label index refreshed Oct 8, 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.
🧪 Avoiding an ingredient? See Benzoyl Peroxide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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 F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
-
UNII LAV5U5022Y
Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
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, docusate sodium, methyl salicylate, purified water, propylene glycol, sodium hydroxide,
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
LabelerAkron Pharma Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code71399
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio44 products on file
More NDCs from Akron Pharma Inc. labeler code 71399
- Urea Cream 40% 400 mg/g Cream NDC 71399-8456-1
- OneLAX BISACODYL 10 mg Suppository NDC 71399-8460-2
- Low Dose Aspirin 81 mg Tablet, Coated NDC 71399-8627-1
- fexofenadine hcl 60 mg Tablet, Film Coated NDC 71399-8659-1
- MEDPURA Benzoyl Peroxide 50 mg/mL Liquid NDC 71399-9234-5
- MEDPURA Benzoyl Peroxide 100 mg/mL Liquid NDC 71399-9236-5
- MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 50 mg/mL Gel NDC 71399-9478-5
- Regular Strength Assorted Flavors Antacid Calcium carbonate 500 mg Tablet, Chewable NDC 71399-9939-1
- Regular Strength Antacid Peppermint Calcium Carbonate 500 mg Tablet, Chewable NDC 71399-9940-1
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 8, 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 Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. 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 ▾
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 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
(1-800-222-1222)
📦 Storage and Handling ▾
Other information store at 20°-25°C (68°-77°F)
🧪 Active Ingredient ▾
Active ingredient Benzoyl peroxide 5% Benzoyl peroxide 10% Purpose Acne treatment
🧪 Inactive Ingredients ▾
Inactive ingredients carbomer, docusate sodium, methyl salicylate, purified water, propylene glycol, sodium hydroxide,
🎯 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 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.
📄 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. (1-800-222-1222)
📄 Questions or Comments ▾
Questions or comments? call toll-free 1-877-225-6999
📄 Package Label / Principal Display Panel ▾
1 2 3 4 5 6
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 MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel (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.
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 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 Akron Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (71399-9474-06), 1 tube (71399-9474-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Akron Pharma 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.