benzoyl peroxide 5 g/100g Gel
by Padagis Israel Pharmaceuticals Ltd · 1 TUBE in 1 CARTON (45802-216-01) / 90 g in 1 TUBE
NDC 45802-0216-01
🏷️ FDA NDC (as labeled)
45802-216-01
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.2164/unit — full pricing hub ↓
Also comes in:
60 g 45802-0216-96
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)
45802-216-01
Product NDC
45802-216
11-digit billing NDC
45802021601
NCPDP billing unit
GM — per gram (weight)
RxCUI
308694
UNII
W9WZN9A0GM
Application #
M006
SPL Set ID
7441981a-654d-4f18-be21-66c863ee6d6f
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2012-03-13
Route
TOPICAL
Dosage form
GEL
Substance
BENZOYL PEROXIDE
GPI-14
90050010004010
GPI class
Benzoyl Peroxide
GCN Seq No
005813
GCN
22931
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 5% GEL
FDB brand name
Benzoyl Peroxide
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 45802-216-01 — 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 → 45802-0216-01. 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
LabelerPadagis Israel Pharmaceuticals Ltd
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code45802
First marketedMar 2012
Product typeHuman Otc Drug
Portfolio175 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 BENZOYL PEROXIDE 5% 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 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 Z135WT9208
Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
-
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
-
UNII P160Q81342
A synthetic cleaning agent derived from lauryl alcohol and succinic acid. It acts as a surfactant and emulsifier to help blend oil and water components, and may aid in drug dissolution and absorption in liquid or semi-solid 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII JX0HIX6OAG
Poloxamer 182 is a synthetic polymer made from ethylene oxide and propylene oxide. It acts as a solubilizer and emulsifier, helping mix water and oil-based ingredients together in liquid medications.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, 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.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 | $0.179 | $16.15 / 90 g |
| Medicaid paysCMS SDUD · 12 mo | $0.2164 | $19.48 / 90 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
Flat over the last 9 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 |
|---|---|---|---|---|---|---|
| benzoyl peroxide 5 g/100gthis 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 | +21% |
| Rugby Benzoyl Peroxide Acne Medication 50 mg/g 00536-1467-25 | Rugby | 1 tube | $0.217 | — | Availability likely | +21% |
| 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/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 | — |
| Acne Control Serum 5 g/100g 72957-0001-01 | Private | 32 g | — | — | FDA listed | — |
| Proactiv Emergency Blemish Relief 5 g/100g 11410-0012-09 | Alchemee, | 1 tube | — | — | FDA listed | — |
| Dermisa Acne Treatment 5 g/100g 68343-0123-01 | Montani | 28 g | — | — | FDA listed | — |
| Dermaharmony 5% Benzoyl Peroxide Cleansing Bar 5 g/100g 71819-0013-04 | D3 | 113 g | — | — | FDA listed | — |
| Zmztuhua Folliculitis Treatment Cream 5 g/100g 87298-0051-01 | Guangzhou | 100 g | — | — | FDA listed | — |
| Folliculitis Treatment Cream 5 g/100g 87298-0060-01 | Guangzhou | 100 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
🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 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 45802-0216-01, 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
15.8K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$301.8K
Avg / prescription
$19.16
Avg / unit
$0.2164
Latest quarter Q4 2025
3.6KRx
Medicaid pays / g
$0.2164
gross reimbursed
vs
NADAC / g
$0.1794
acquisition cost
=
Spread
+$0.0370
+21% vs cost
What Medicaid paid per g (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 · 9,282 Rx Managed care · 6,468 Rx
State Medicaid map
Units reimbursed · per 100k residents
74.02,240
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.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 59,809 Rx · 4,053,738 units · $986,326 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 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
Age at onset
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 45802-0216-01 You're viewing this | 1 TUBE in 1 CARTON (45802-216-01) / 90 g in 1 TUBE | $0.1794 / g | $16.14 | 2012-04-06 | Active |
| 45802-0216-96 | 1 TUBE in 1 CARTON (45802-216-96) / 60 g in 1 TUBE | $0.2173 / g | $13.04 | 2012-03-13 | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.1794 NADAC).
This pack accounts for about 26% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 45802-0216-01?
NDC 45802-0216-01 is listed by the FDA — 1 tube in 1 carton / 90 g in 1 tube.
What NDC number is used to bill for this package of benzoyl peroxide 5 g/100g Gel?
Bill NDC 45802-0216-01 — the 11-digit billing format is 45802021601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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 • 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 if you • have very sensitive skin • 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. Stop use and ask a doctor if • irritation becomes severe 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%
🧪 Inactive Ingredients ▾
Inactive ingredients carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide
🎯 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.