FDA-filed SPL labeling · retrieved through openFDA

Erythromycin and Benzoyl Peroxide Topical

Erythromycin and benzoyl peroxide is a combination topical antibiotic and skin-clearing gel used to treat acne vulgaris.

Brand name Benzamycin
Drug class Macrolide Antimicrobial
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveSep 5, 2025
Clinical labels in scope 3
AvailabilityRx
Earliest approval/marketing year 1984
FDA-listed product records 7
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Erythromycin and Benzoyl Peroxide Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Erythromycin and Benzoyl Peroxide Topical Gel is a two-ingredient combination that treats acne vulgaris by fighting bacteria and helping clear clogged pores. Use it twice daily as directed, and keep it refrigerated after your pharmacist mixes it. Contact your doctor if you develop significant diarrhea, as that can occasionally be a sign of a serious antibiotic-related intestinal problem.

📖 Erythromycin and Benzoyl Peroxide Topical: Patient Information Guide

A plain-language walkthrough of Erythromycin and Benzoyl Peroxide Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Erythromycin and benzoyl peroxide topical gel is approved for one main purpose:

  • Treatment of acne vulgaris — Erythromycin and Benzoyl Peroxide Topical Gel USP is applied to the skin to treat common acne.
⚙️How it works

This combination gel tackles acne in two ways. Erythromycin is an antibiotic that works by binding to a part of bacterial cells (the 50S ribosomal subunit) and blocking their ability to make proteins — which stops them from multiplying. Benzoyl peroxide attacks acne-causing bacteria (Propionibacterium acnes) by releasing active oxygen, and it also has a keratolytic effect, loosening and shedding dead skin cells to help keep pores clear.

It's worth knowing that erythromycin can interfere with certain other antibiotics — specifically lincomycin, chloramphenicol, and clindamycin — so those should not be used at the same time without your doctor's guidance.

💊How it's taken

Apply Erythromycin and Benzoyl Peroxide Topical Gel USP twice a day — morning and evening — to the areas where you have acne. Before each application:

  • Wash the skin thoroughly.
  • Rinse with warm water.
  • Gently pat dry, then apply the gel.

This gel is mixed by your pharmacist before it's dispensed and must be kept refrigerated (not frozen) after mixing. It expires 3 months after preparation, so check the date on your label. Follow your prescriber's directions — your schedule may be adjusted.

🤒Side effects — in detail

Most side effects from this gel are mild and happen right where you apply it. Common ones include:

  • Skin dryness
  • Peeling
  • Itching
  • Burning sensation
  • Redness
  • Skin oiliness or tenderness
  • Hive-like skin reactions
  • Irritation of the face, eyes, or nose

If you develop significant diarrhea — especially if it's severe, bloody, or comes with stomach cramps — contact your doctor right away, as this can be a sign of a serious intestinal problem linked to antibiotic use.

⚠️Warnings & precautions

The most significant risk to be aware of is pseudomembranous colitis — a serious infection of the colon caused by an overgrowth of Clostridium difficile bacteria. This can happen with nearly any antibiotic, including the erythromycin in this gel. Symptoms range from mild diarrhea to severe, life-threatening illness. If you have diarrhea after starting this gel, tell your doctor promptly.

Do not use this gel if you are allergic to erythromycin, benzoyl peroxide, or any other ingredient it contains. If you notice signs of a serious skin reaction or allergic response, stop using it and seek medical attention.

🔀What it interacts with

There is one key drug interaction to be aware of with the erythromycin in this gel:

  • Lincomycin, clindamycin, and chloramphenicol — these antibiotics have been shown in lab studies to work against erythromycin, potentially reducing its effectiveness. Avoid combining them without medical guidance.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your doctor or pharmacist if you have ever had an allergic reaction to erythromycin, benzoyl peroxide, or any ingredient in this gel — it is contraindicated if you have.
  • Let your doctor know if you develop diarrhea while using this gel, especially if it is watery, bloody, or persistent.
📡Pharmacodynamics — effects in the body

Erythromycin reduces acne lesions partly through its antibacterial activity against Propionibacterium acnes, bacteria found in sebaceous (oil-producing) follicles and comedones. Benzoyl peroxide has a keratolytic and desquamative effect — it helps break down and shed the outer layer of skin, which may help clear blocked pores and reduce acne.

🔬Pharmacokinetics — how your body processes it

Benzoyl peroxide is absorbed through the skin, where it is converted to benzoic acid. The label does not provide further absorption, distribution, or elimination details for either ingredient as used topically.

📦How to store it

store at room temperature between 15° to 30°C (59° to 86°F). store under refrigeration between 2° to 8°C (36° to 46°F). Do not freeze.

📄 Written from Erythromycin and Benzoyl Peroxide Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Erythromycin and Benzoyl Peroxide Topical — the kind of thing our pharmacy team would talk through with you at the counter.

What is this gel actually for?
This gel is a prescription treatment for acne vulgaris — the everyday kind of acne that causes pimples, blackheads, and red inflamed spots. It combines two ingredients that work together to fight acne-causing bacteria and help clear your skin.
How and when should I apply it?
Apply it twice a day — once in the morning and once at night. Before you put it on, wash the area with soap, rinse with warm water, and gently pat your skin dry. Then apply the gel to the affected areas. Sticking to this routine is important for it to work well.
Do I need to refrigerate it?
Yes — your pharmacist mixes this gel before dispensing it, and once it's mixed it must be kept in the refrigerator. Don't freeze it. It also has a 3-month expiration date from the time it's prepared, so check the date written on your label and don't use it past that point.
What side effects should I expect?
The most common ones are skin dryness, peeling, redness, itching, or a mild burning sensation where you apply it. These are usually mild. If you notice hives or more serious skin irritation, let your doctor know.
Should I be worried about diarrhea while using this?
It's something to watch for. Even though you're applying this to your skin rather than swallowing it, the erythromycin can occasionally cause an intestinal problem called pseudomembranous colitis. If you develop new or worsening diarrhea — especially if it's severe, bloody, or comes with stomach cramps — call your doctor right away rather than waiting it out.
Can I use this with other acne antibiotics?
Not necessarily. The erythromycin in this gel can conflict with certain other antibiotics — specifically clindamycin, lincomycin, and chloramphenicol — and using them together could make the erythromycin work less well. Always tell your prescriber and pharmacist about any other medications you're using so they can check for this.
Is Erythromycin and Benzoyl Peroxide Topical available over the counter?
Erythromycin and Benzoyl Peroxide Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Erythromycin and Benzoyl Peroxide Topical first available?
Erythromycin and Benzoyl Peroxide Topical has been available in the United States since at least 1984, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Erythromycin and Benzoyl Peroxide Topical?
Erythromycin and Benzoyl Peroxide Topical is supplied by 5 manufacturers listed in the FDA NDC Directory, including Sandoz Inc., Oceanside Pharmaceuticals, Bausch Health US, LLC.

💬 Answers drafted from Erythromycin and Benzoyl Peroxide Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Erythromycin and Benzoyl Peroxide Topical comes

Erythromycin and Benzoyl Peroxide Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
How this form is used
What it may be used for
  • Erythromycin and Benzoyl Peroxide Topical Gel USP is used for the topical treatment of acne vulgaris.
Important instructions
  • Erythromycin and Benzoyl Peroxide Topical Gel USP should be applied twice daily — in the morning and evening — to affected areas.
  • Erythromycin and Benzoyl Peroxide Topical Gel USP should be applied after the skin is thoroughly washed, rinsed with warm water, and gently patted dry.
  • Erythromycin and Benzoyl Peroxide Topical Gel USP must be stored in the refrigerator after mixing by the pharmacist — do not freeze.
  • Erythromycin and Benzoyl Peroxide Topical Gel USP has a 3-month expiration date once it has been mixed; check the label for your specific date.
Available strengths 2 strengths
2 FDA-listed product records

📊 Erythromycin and Benzoyl Peroxide Topical across the U.S. market

How Erythromycin and Benzoyl Peroxide Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
5
Manufacturers
2
Brand names
7
FDA-listed product records
1984
First marketed

Also listed with the FDA, not a patient dose form: Kit (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Sandoz Inc.29%
Oceanside Pharmaceuticals29%
Bausch Health US, LLC14%
Rising Pharmaceuticals, Inc.14%
Rising Pharma Holdings, Inc.14%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Erythromycin and Benzoyl Peroxide Topical is used

A general measure of how commonly Erythromycin and Benzoyl Peroxide Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Erythromycin and Benzoyl Peroxide Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

38,628
Medicaid prescriptions filled (Q1–Q4 2025)
$2.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Erythromycin and Benzoyl Peroxide Topical prescribed? Of the 1,594 medications we measure, Erythromycin and Benzoyl Peroxide Topical ranks #685 by Medicaid prescriptions — more than 57% of them.

Where Erythromycin and Benzoyl Peroxide Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Erythromycin and Benzoyl Peroxide Topical product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Erythromycin and Benzoyl Peroxide Topical products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

38,628 Medicaid prescriptions (Q1–Q4 2025) 100% of Erythromycin and Benzoyl Peroxide Topical prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $55 per prescription (gross)

Summed across the 5 of 7 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Erythromycin and Benzoyl Peroxide Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 7 listed Erythromycin and Benzoyl Peroxide Topical NDCs with Medicaid activity.

🔍 Compare Erythromycin and Benzoyl Peroxide Topical products

A representative set of FDA-listed product records for Erythromycin and Benzoyl Peroxide Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Topical cream, ointment or gel
50; 30 mg/g; mg/g Topical Rising Pharmaceuticals, Inc. ANDA View NDC →
ERYTHROMYCIN 30 mg/g; BENZOYL PEROXIDE 50 mg/g Topical Rising Pharma Holdings, Inc. ANDA View NDC →
💊Kits
Bausch Health US, LLC NDA View NDC →
Oceanside Pharmaceuticals × 2 listings NDA AUTHORIZED GENERIC View NDC →
Topical Sandoz Inc. × 2 listings ANDA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Erythromycin and Benzoyl Peroxide Topical NDCs →

🏷️ Sold under these brand names

Benzamycin

🏭 Manufacturers & labelers

Sandoz Inc. 2 Oceanside Pharmaceuticals 2 Bausch Health US, LLC 1 Rising Pharmaceuticals, Inc. 1 Rising Pharma Holdings, Inc. 1

RxNorm drug class

Erythromycin and Benzoyl Peroxide Topical belongs to the Peroxides class.

Drug family (ATC) Peroxides

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 5, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Erythromycin and Benzoyl Peroxide Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Erythromycin and Benzoyl Peroxide Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
7
Distinct labelers/manufacturers represented
5
Linked representative label
Rising Pharma Holdings, Inc.
Linked label effective
Sep 5, 2025
Composite sections available
13
Linked SPL Set ID
d449d7e2-5c25-406d-87ab-30809d292476
Linked SPL Document ID
8547932c-ed72-4e13-b8fe-2b78919399d5
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Rising Pharma Holdings, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.