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adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g Gel, 45 g — NDC 45802-0846-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g Gel, 45 g — NDC 45802-846-01 (Billing 45802-0846-01) · Product 45802-846

by Padagis Israel Pharmaceuticals Ltd · 45 g in 1 BOTTLE, PUMP (45802-846-01)

NDC 45802-846-01 (billing 45802-0846-01) is a package of 45 g of adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g Gel from Padagis Israel Pharmaceuticals Ltd, marketed since Jan 2018 and currently FDA-listed; retail pharmacies pay about $0.3682 per g (NADAC). It is the main listing for product NDC 45802-846, its only package size.

NDC 45802-0846-01
🏷️ FDA NDC (as labeled) 45802-846-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-846-01
Product NDC 45802-846
11-digit billing NDC 45802084601
NCPDP billing unit GM — per gram (weight)
RxCUI 829539
UNII 1L4806J2QF, W9WZN9A0GM
Application # ANDA205033
SPL Set ID e50e3ef9-3a9b-4172-a908-71c973a7fb5c
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-24
Route TOPICAL
Dosage form GEL
Substance ADAPALENE; BENZOYL PEROXIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90059902034020
GPI class Adapalene-Benzoyl Peroxide
GCN Seq No 068880
GCN 31775
HICL code 036015
Ingredient (HICL) Adapalene/Benzoyl Peroxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name ADAPALENE-BNZYL PEROX 0.1-2.5%
FDB brand name Adapalene-Benzoyl Peroxide
Legend status F — Federal legend — prescription drug or device
Quick answers for NDC 45802-846-01
  • GSN (GCN sequence number): 068880
  • GCN: 31775
  • GPI-14 (Medi-Span): 90059902034020
  • HICL (First Databank): 036015
  • AHFS class code: 84:92.00.00
  • RxCUI (RxNorm): 829539
  • 11-digit billing NDC: 45802084601
Why two NDCs? The FDA registers this code as 45802-846-01 — 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 → 45802-0846-01. 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.

Clinical

Label name ADAPALENE-BNZYL PEROX 0.1-2.5% Ingredient Adapalene/Benzoyl Peroxide

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.368 $16.57 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.6176 $27.79 / 45 g
Medicare drug plans payPart D · Q2 2026 $1.13 $50.85 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.908 $0.282
▼ Down 49% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
45802-0846-01 45802-846-01 You're viewing this Main listing 45 g in 1 BOTTLE, PUMP (45802-846-01) 2018-01-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g; 25 mg/g 21922-0052-50 Encube 1 bottle $0.368 AB Availability likely —
adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100gthis 45802-0846-01 Padagis 45 g $0.368 AB Availability likely —
ADAPALENE and BENZOYL PEROXIDE 1 mg/g; 25 mg/g 51672-1364-03 Sun 1 bottle $0.368 AB Availability likely —
adapalene and benzoyl peroxide 1 mg/g; 25 mg/g 68462-0301-47 Glenmark 1 bottle $0.368 AB Availability likely —
Differin Epiduo 1 mg/g; 25 mg/g 00299-4908-00 Galderma 2 g — — FDA listed —
adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 63629-8607-01 Bryant 1 bottle — AB FDA listed —
adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 72162-1430-02 Bryant 45 g — AB FDA listed —
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g; 25 mg/g 72162-2296-02 Bryant 1 bottle — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

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

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA205033 (ANDA)
Labeler code45802
First marketedJan 2018
Product typeHuman Prescription 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 64 words ▾

1 INDICATIONS AND USAGE Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ( 1 )

⏱️ Dosage and Administration 132 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only; Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek).

Avoid the eyes, lips and mucous membranes. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply a thin film of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to affected areas of the face and/or trunk once daily after washing.

Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. ( 2 )

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS Each gram of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel. Each gram of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. ( 5.1 ) Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and may necessitate discontinuation. ( 5.2 )

5.1Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during the use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel, (e.g., hat) are recommended when exposure cannot be avoided.

Weather extremes, such as wind or cold, may be irritating to patients under treatment with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

5.2Local Cutaneous Reactions Erythema, scaling, dryness, and stinging/burning may be experienced with use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur.

Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most commonly reported adverse events (≥1%) in patients treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel, 0.1%/2.5%. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months.

Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with adapalene and benzoyl peroxide gel, 0.1%/2.5% and those reported in subjects treated with the vehicle gel are presented in Table 1: Table 1 Drug Related Adverse Events Reported in Clinical Trials by At Least 1% of Patients Treated For 12 Weeks System Organ Class/Preferred Term Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% N=564 Vehicle gel N=489 Subjects with AE (s) 14% 4% Dry Skin 7% 2% Contact dermatitis 3% <1% Application site burning 2% <1% Application site irritation 1% <1% Skin irritation 1% 0% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging.

Table 2 Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N=553) Treatment Emergent Signs and Symptoms Maximum Severity During Treatment End of Treatment Severity (12 Weeks) Mild Moderate Severe Mild Moderate Severe Erythema 27% 13% 1% 8% 2% 1% Scaling 35% 11% 1% 9% 1% <1% Dryness 41% 13% 1% 10% 2% <1% Stinging/burning 41% 15% 3% 7% 2% 1% Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.

During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with adapalene and benzoyl peroxide gel, 0.1%/2.5% or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of adapalene and benzoyl peroxide gel, 0.1%/2.5% in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of adapalene and benzoyl peroxide gel, 0.1%/2.5%: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

🔄 Drug Interactions 44 words ▾

7 DRUG INTERACTIONS Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATION

8.1Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide.

Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively.

Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m 2 ) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

8.3Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Because many drugs are excreted in human milk, caution should be exercised when Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in pediatric patients under the age of 9 have not been established.

8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel, 0.1%/2.5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 195 words ▾

8.1Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide.

Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively.

Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m 2 ) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

🧒 Pediatric Use 25 words ▾

8.4Pediatric Use Safety and effectiveness of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in pediatric patients under the age of 9 have not been established.

🧓 Geriatric Use 32 words ▾

8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel, 0.1%/2.5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology 212 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.

12.2Pharmacodynamics Pharmacodynamics of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is unknown.

12.3Pharmacokinetics A pharmacokinetic study was conducted in 10 adult subjects with acne vulgaris who were treated once daily for 30 days with 2 grams/day of adapalene and benzoyl peroxide gel, 0.1%/2.5% applied to 1000 cm 2 of acne involved skin, (face, chest, and upper back). Two subjects (20%) had quantifiable adapalene plasma concentrations above the limit of quantification (LOQ = 0.1ng/mL). The highest adapalene C max and AUC 0-24h was 0.21 ng/mL and 1.99 ng•h/mL, respectively.

Excretion of adapalene appears to be primarily by the biliary route. Pharmacokinetics of adapalene and benzoyl peroxide gel, 0.1%/2.5% in pediatric subjects have not been evaluated. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram tube NDC 45802- 846 -84 45 gram pump NDC 45802- 846 -01 Storage and handling - Store at 25°C; excursions permitted to 15° – 30°C (59° – 86°F). - Protect from light. - Keep out of reach of children. - Keep away from heat. - Keep tube tightly closed.

📋 Description 127 words ▾

11 DESCRIPTION Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid).

It has the following structural formula: Adapalene: Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide: Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. chemical structure adapalene.jpg chemical structure benzoyl peroxide.jpg

💬 Information for Patients 139 words ▾

17 PATIENT COUNSELING INFORMATION [ See FDA Approved Patient Labeling (Patient Information) ] Information for Patients - Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% as a thin layer, avoiding the eyes, lips and mucous membranes. - Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. - Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may cause irritation such as erythema, scaling, dryness, stinging or burning. - Advise patients to minimize exposure to sunlight, including sunlamps.

Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided. - Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% may bleach hair and colored fabric.

🍼 Nursing Mothers 51 words ▾

8.3Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Because many drugs are excreted in human milk, caution should be exercised when Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is administered to a nursing woman.

🧬 Pharmacokinetics 122 words ▾

12.3Pharmacokinetics A pharmacokinetic study was conducted in 10 adult subjects with acne vulgaris who were treated once daily for 30 days with 2 grams/day of adapalene and benzoyl peroxide gel, 0.1%/2.5% applied to 1000 cm 2 of acne involved skin, (face, chest, and upper back). Two subjects (20%) had quantifiable adapalene plasma concentrations above the limit of quantification (LOQ = 0.1ng/mL). The highest adapalene C max and AUC 0-24h was 0.21 ng/mL and 1.99 ng•h/mL, respectively.

Excretion of adapalene appears to be primarily by the biliary route. Pharmacokinetics of adapalene and benzoyl peroxide gel, 0.1%/2.5% in pediatric subjects have not been evaluated. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.

🧬 Pharmacodynamics 12 words ▾

12.2Pharmacodynamics Pharmacodynamics of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is unknown.

🔬 Clinical Studies ~3 min read ▾

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel, 0.1%/2.5%. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months.

Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with adapalene and benzoyl peroxide gel, 0.1%/2.5% and those reported in subjects treated with the vehicle gel are presented in Table 1: Table 1 Drug Related Adverse Events Reported in Clinical Trials by At Least 1% of Patients Treated For 12 Weeks System Organ Class/Preferred Term Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% N=564 Vehicle gel N=489 Subjects with AE (s) 14% 4% Dry Skin 7% 2% Contact dermatitis 3% <1% Application site burning 2% <1% Application site irritation 1% <1% Skin irritation 1% 0% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging.

Table 2 Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N=553) Treatment Emergent Signs and Symptoms Maximum Severity During Treatment End of Treatment Severity (12 Weeks) Mild Moderate Severe Mild Moderate Severe Erythema 27% 13% 1% 8% 2% 1% Scaling 35% 11% 1% 9% 1% <1% Dryness 41% 13% 1% 10% 2% <1% Stinging/burning 41% 15% 3% 7% 2% 1% Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.

During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with adapalene and benzoyl peroxide gel, 0.1%/2.5% or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of adapalene and benzoyl peroxide gel, 0.1%/2.5% in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.

14 CLINICAL STUDIES The safety and efficacy of adapalene and benzoyl peroxide gel, 0.1%/2.5% applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing adapalene and benzoyl peroxide gel, 0.1%/2.5% to the gel vehicle in acne subjects. Treatment response was defined as the percent of subjects who had a two grade improvement and rated ‘Clear’ and ‘Almost Clear’ at Week 12 based on the Investigator’s Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts.

An IGA score of ‘Clear’ corresponded to residual hyperpigmentation and erythema may be present. An IGA score of ‘Almost Clear’ corresponded to a few scattered comedones and a few small papules. In Study 1, 517 subjects were randomized to adapalene and benzoyl peroxide gel, 0.1%/2.5%, adapalene 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel.

The median age of these 517 subjects was 15 years old and 60% were males. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects had a baseline IGA score of ‘Moderate’ which corresponded to more than half of the face is involved, many comedones, papules and pustules.

The efficacy results at week 12 are presented in Table 3. In Study 2, 1668 subjects were randomized to adapalene and benzoyl… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide gel, 0.1%/2.5%. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day), and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%.

In the rat study, an increased incidence of benign and malignant pheochromcytomas in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15-25% benzoyl peroxide carbopol gel (6-10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide gel, 0.1%/2.5%) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg.

In terms of body surface area, these levels are 27-40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 years study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. The role of benzoyl peroxide as a tumor promoter has been well established in several animal species.

However, the significance of this finding in humans is unknown. In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks. No photocarcinogenicity studies were conducted with adapalene.

However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test).

Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results, mutagenic potential was observed in a few but not in a majority of investigations. Benzoyl peroxide has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, it has caused DNA-protein cross-links in the human cells, and has also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells. In rat oral studies, 20 mg adapalene/kg/day (120 mg/m 2 /day; 98 times the MRHD based on mg/m 2 /day comparison) did not affect the reproductive performance and fertility of F 0 males and females, or growth, development and reproductive function of F 1 offspring.

No fertility studies were conducted with benzoyl peroxide.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide gel, 0.1%/2.5%. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day), and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%.

In the rat study, an increased incidence of benign and malignant pheochromcytomas in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15-25% benzoyl peroxide carbopol gel (6-10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide gel, 0.1%/2.5%) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg.

In terms of body surface area, these levels are 27-40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 years study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. The role of benzoyl peroxide as a tumor promoter has been well established in several animal species.

However, the significance of this finding in humans is unknown. In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks. No photocarcinogenicity studies were conducted with adapalene.

However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test).

Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results, mutagenic potential was observed in a few but not in a majority of investigations. Benzoyl peroxide has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, it has caused DNA-protein cross-links in the human cells, and has also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells. In rat oral studies, 20 mg adapalene/kg/day (120 mg/m 2 /day; 98 times the MRHD based on mg/m 2 /day comparison) did not affect the reproductive performance and fertility of F 0 males and females, or growth, development and reproductive function of F 1 offspring.

No fertility studies were conducted with benzoyl peroxide.

📄 Patient Package Insert ~3 min read ▾

Patient Information Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% Important: For use on the skin only (topical). Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in or on your mouth, eyes, or vagina. Read this Patient Information leaflet about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% before you start using it and each time you get a refill.

There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, talk with your doctor or pharmacist.

What is Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is safe and effective in children younger than 9 years old. What should I tell my doctor before using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? Before you use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, tell your doctor if you: • have other skin problems, including cuts or sunburn • have any other medical conditions • are pregnant or planning to become pregnant.

It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed. It is not known if Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% passes into your breast milk and if it can harm your baby.

Talk to your doctor about the best way to feed your baby if you use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use any other medicine for acne.

Using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? • Use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% exactly as your doctor tells you to use it. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is for skin use only. Do not use Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% in or on your mouth, eyes, or vagina. • Apply Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 time a day. • Do not use more Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% than you need to cover the treatment area.

Using too much Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% or using it more than 1 time a day may increase your chance of skin irritation. Applying Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%: • Wash the area where the gel will be applied with a mild cleanser and pat dry. • Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% comes in a tube and a pump. If you have been prescribed the: o Tube: Squeeze a small amount (about the size of a pea) of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% onto your fingertips and spread a thin layer over the affected area. o Pump: Depress the pump to dispense a small amount (about the size of a pea) of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and spread a thin layer over the affected area.

What should I avoid while using Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%? • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% if you have to be in sunlight. • You should avoid… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 27 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Label NDC 45802- 846 -01 Rx Only Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% Pump For Topical Use Only NET WT 45 g label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 45802-0846-01, 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 – Q1 2026 · 5 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
8.6K
Units reimbursed last 4 qtrs
389.1K
Gross reimbursed last 4 qtrs
$240.3K
Avg / prescription
$28.06
Avg / unit
$0.6176
Latest quarter Q1 2026
3.3KRx
Medicaid pays / g
$0.6176
gross reimbursed
vs
NADAC / g
$0.3682
acquisition cost
=
Spread
+$0.2494
+68% 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 ⓘ
41% FFS 59% MCO
Fee-for-service · 3,515 Rx Managed care · 5,048 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,960 units · 50.7 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 5,115 units · 51.0 per 100k residents MI New York: 64,090 units · 327 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 1,440 units · 45.1 per 100k residents NV Wyoming: no data reported WY South Dakota: 540 units · 58.8 per 100k residents SD Iowa: 1,800 units · 56.1 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,655 units · 22.5 per 100k residents OH Pennsylvania: 10,305 units · 79.5 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 76,695 units · 197 per 100k residents CA Utah: no data reported UT Colorado: 1,620 units · 27.6 per 100k residents CO Nebraska: 1,305 units · 66.0 per 100k residents NE Missouri: no data reported MO Kentucky: 1,260 units · 27.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 1,035 units · 16.7 per 100k residents MD Connecticut: 17,235 units · 476 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 2,160 units · 73.5 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 13,095 units · 121 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 7,245 units · 246 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 8,550 units · 28.0 per 100k residents TX Florida: 168,975 units · 747 per 100k residents FL
Units reimbursed · per 100k residents
16.7747
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
🏆 Top states by units · per 100k residents
1 Florida 747 /100k
2 Connecticut 476 /100k
3 New York 327 /100k
4 Mississippi 246 /100k
5 California 197 /100k
6 North Carolina 121 /100k
7 Pennsylvania 79.5 /100k
8 Kansas 73.5 /100k
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.

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 Adapalene and benzoyl peroxide — the ingredient across all brands.

Top reported reactions

Skin Burning Sensation80
Erythema79
Dry Skin64
Acne45
Skin Irritation45
Skin Exfoliation40
Rash35

Age at onset

Adolescent13
Adult21

Reporter sex

418 reports
Male · 28%
Female · 69%
Unknown · 3%

Serious outcomes

Hospitalization19
Life-threatening2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 68 0
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.
← 45802-0827-25 · Padagis 45802-0847-78 · Padagis →
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.