Quick answers
- What is Erythromycin and benzoyl peroxide used for?
- The FDA-approved label (Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., September 5, 2025) says: “Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Erythromycin and benzoyl peroxide?
- The “Adverse Reactions” section of the FDA label (Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., September 5, 2025) begins: “In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin and Benzoyl Peroxide Topical Gel USP was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Erythromycin and benzoyl peroxide have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Erythromycin and benzoyl peroxide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Erythromycin and benzoyl peroxide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Erythromycin and benzoyl peroxide?
- 1 company lists prescription products of Erythromycin and benzoyl peroxide in the FDA NDC Directory, including Rising Pharma Holdings, Inc.
What Erythromycin and benzoyl peroxide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
— FDA label: Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (gel, topical), Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Erythromycin and benzoyl peroxide side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin and Benzoyl Peroxide Topical Gel USP was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes.
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Skin discoloration, oiliness and tenderness of the skin have also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025. Read the full label on DailyMed →
Erythromycin and benzoyl peroxide dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Erythromycin and Benzoyl Peroxide Topical Gel USP should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
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How Supplied and Compounding Directions Size (Net weight) NDC Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 64980-328-01 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 64980-328-02 40 grams 1.6 grams 6 mL Pharmacist Important - Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ETHYL ALCOHOL to vial (to the mark) and immediately shake vigorously to completely dissolve erythromycin, then immediately add this solution to gel and stir until homogeneous in appearance (1 to 1-1/2 minutes). Erythromycin and Benzoyl Peroxide Topical Gel USP should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. Note: Prior to reconstitution, store at room temperature between 15˚ and 30˚C (59˚-86˚F). After reconstitution, store under refrigeration between 2˚and 8˚C (36˚-46˚F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Rx only Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301 Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 Revised: 08/2025 PIR32846-00
Table from the label
| Size (Net weight) | NDC | Benzoyl Peroxide Gel | Active Erythromycin Powder (In Plastic Vial) | 70% Ethyl Alcohol To Be Added |
|---|---|---|---|---|
| 23.3 grams (as dispensed) | 64980-328-01 | 20 grams | 0.8 grams | 3 mL |
| 46.6 grams (as dispensed) | 64980-328-02 | 40 grams | 1.6 grams | 6 mL |
— FDA label: Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025. Read the full label on DailyMed →
Erythromycin and benzoyl peroxide in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Teratogenic Effects: Animal reproduction studies have not been conducted with Erythromycin and Benzoyl Peroxide Topical Gel USP or benzoyl peroxide. There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters.
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There are no well-controlled trials in pregnant women with Erythromycin and Benzoyl Peroxide Topical Gel USP. It also is not known whether Erythromycin and Benzoyl Peroxide Topical Gel USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin and Benzoyl Peroxide Topical Gel USP should be given to a pregnant woman only if clearly needed.
— FDA label: Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025. Read the full label on DailyMed →
Erythromycin and benzoyl peroxide and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Nursing Women: It is not known whether Erythromycin and Benzoyl Peroxide Topical Gel USP is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
— FDA label: Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025. Read the full label on DailyMed →
When Erythromycin and benzoyl peroxide should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.
— FDA label: Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Gel |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| benzoyl peroxide 5% · erythromycin 3% gel | Generic | $0.9890–$1.65 per gram 2 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Rising Pharma Holdings, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA065385Rising · September 18, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 244374 |
|---|---|
| SPL set ID of the quoted label | d449d7e2-5c25-406d-87ab-30809d292476 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | BENZOYL PEROXIDE / ERYTHROMYCIN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Rising Pharma Holdings, Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Erythromycin and Benzoyl Peroxide, Rising Pharma Holdings, Inc., effective September 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →