Erythromycin and Benzoyl Peroxide 30 mg/g; 50 mg/g Gel, 23.3 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Peroxides class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
The combination of erythromycin and benzoyl peroxide is used to treat acne. Erythromycin and benzoyl peroxide are in a class of medications called topical antibiotics. The combination of erythromycin and benzoyl peroxide works by killing the bacteria that cause acne.
Read the full MedlinePlus article ↗- 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 to...
- 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...
- 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...
- 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 i...
Patient education
Supplement & herbal interactions
Where does this data come from?
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.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
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UNII F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
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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.
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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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $1.601 | $37.31 / 23.3 g |
| Medicaid paysCMS SDUD · 12 mo | $1.85 | $43.13 / 23.3 g |
| Medicare drug plans payPart D · Q2 2026 | $1.57 | $36.68 / 23.3 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Erythromycin and Benzoyl Peroxide 68682-0901-46 | Oceanside | 1 kit | $1.078 | AB | FDA listed | save 33% |
| Erythromycin and Benzoyl Peroxide 68682-0900-23 | Oceanside | 1 kit | $1.593 | AB | FDA listed | save 1% |
| Erythromycin and Benzoyl Peroxide 30 mg/g; 50 mg/gthis 64980-0328-01 | Rising | 23.3 g | $1.601 | AB | Availability likely | — |
| Benzamycin 00187-5205-46 | Bausch | 1 kit | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 64980-0328-01 You're viewing this | 23.3 g in 1 JAR (64980-328-01) | $1.60 / g | $37.31 | 2016-10-18 | Active |
| 64980-0328-02 | 46.6 g in 1 JAR (64980-328-02) | $1.05 / g | $49.02 | 2016-10-18 | Active |
Per g, this pack runs about 52% above the cheapest pack (46.6 g in 1 JAR (64980-3, $1.05 vs $1.60 NADAC).
This pack accounts for about 35% of this product's recent Medicaid fills; most go to the 46 gs pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 64980-0328-01?
What is the difference between NDC 64980-0328-01 and NDC 64980-0328-02?
What NDC number is used to bill for this package of Erythromycin and Benzoyl Peroxide 30 mg/g; 50 mg/g Gel?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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. 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
⛔ Contraindications ▾
CONTRAINDICATIONS Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.
Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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.
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.
🤰 Pregnancy ▾
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. 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.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.
Microbiology Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol and clindamycin. Benzoyl peroxide is an antibacterial agent which has been shown to be effective against Propionibacterium acnes , an anaerobe found in sebaceous follicles and comedones.
The antibacterial action of benzoyl peroxide is believed to be due to the release of active oxygen.
📦 How Supplied / Storage and Handling ▾
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
📋 Description ▾
DESCRIPTION Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3- C -methyl-3- 0 -methyl-α-L- ribo -hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-dimethylamino)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus ). It is a base and readily forms salts with acids.
Chemically, erythromycin is (C 37 H 67 NO 13 ). It has the following structural formula: Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25˚C.
Erythromycin and Benzoyl Peroxide Topical Gel USP also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ).
It has the following structural formula: Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of Erythromycin and Benzoyl Peroxide Topical Gel USP contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, carbomer 940 NF, ethyl alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.
LABEL LABEL 2
💬 Information for Patients ▾
Information for Patients: Patients using Erythromycin and Benzoyl Peroxide Topical Gel USP should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes.
This medication should not be used for any disorder other than that for which it was prescribed. Patients should not use any other topical acne preparation unless otherwise directed by physician. Patients should report to their physician any signs of local adverse reactions.
Erythromycin and Benzoyl Peroxide Topical Gel USP may bleach hair or colored fabric. Keep product refrigerated and discard after 3 months.