Erythromycin and Benzoyl Peroxide Kit — NDC 68682-901-46 (Billing 68682-0901-46)
This is a package of Erythromycin and Benzoyl Peroxide Kit from Oceanside Pharmaceuticals, marketed since Oct 1984 and currently FDA-listed; retail pharmacies pay about $1.08 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 68682-901-46 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68682 labeler · 901 product · 46 package
- Package marketed since
- Oct 26, 1984
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6868290146 7
- Medicaid fills, this package
- 6,795 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007678
- GCN: 85400
- GPI-14 (Medi-Span): 90059902104010
- HICL (First Databank): 003354
- AHFS class code: 08:12.12.04
- RxCUI (RxNorm): 244374
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Peroxides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $1.078 | — |
| Medicaid paysCMS SDUD · 12 mo | $1.14 | — |
| Medicare drug plans payPart D · Q2 2026 | $1.57 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68682-0901-46 You're viewing this Main listing | 1 KIT in 1 CARTON * 40 g in 1 JAR * 1.6 g in 1 VIAL, PLASTIC | 1984-10-26 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Erythromycin and Benzoyl Peroxidethis 68682-0901-46 | Oceanside | 1 kit | $1.078 | AB | FDA listed | — |
| Erythromycin and Benzoyl Peroxide 68682-0900-23 | Oceanside | 1 kit | $1.593 | AB | FDA listed | +48% |
| Erythromycin and Benzoyl Peroxide 30 mg/g; 50 mg/g 64980-0328-01 | Rising | 23.3 g | $1.599 | AB | Availability likely | +48% |
| Benzamycin 00187-5205-46 | Bausch | 1 kit | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Oceanside Pharmaceuticals labeler code 68682
- Enalapril Maleate 5 mg Tablet NDC 68682-711-01
- Enalapril Maleate 10 mg Tablet NDC 68682-712-01
- Enalapril Maleate 20 mg Tablet NDC 68682-713-01
- Tretinoin .05 g/100g Gel NDC 68682-800-45
- Luliconazole 10 mg/g Cream NDC 68682-850-60
- Erythromycin and Benzoyl Peroxide Kit NDC 68682-900-23
- Tetracaine Hydrochloride 5 mg/mL Solution/ Drops NDC 68682-920-05
- Tolcapone 100 mg Tablet, Film Coated NDC 68682-938-90
- Omeprazole and Sodium Bicarbonate 20 mg; 1680 mg Powder, For Suspension NDC 68682-990-30
- Diltiazem Hydrochloride 120 mg Capsule, Extended Release NDC 68682-993-98
- Diltiazem Hydrochloride 180 mg Capsule, Extended Release NDC 68682-994-98
- Diltiazem Hydrochloride 240 mg Capsule, Extended Release NDC 68682-997-98
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Erythromycin-Benzoyl Peroxide Topical Gel 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Erythromycin-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel 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 Oceanside Pharmaceuticals, at 1-800-321-4576 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-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel.
It also is not known whether Erythromycin-Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin-Benzoyl Peroxide Topical Gel 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 68682- Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 900-23 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 901-46 40 grams 1.6 grams 6 mL 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 to completely dissolve erythromycin . Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes).
Erythromycin-Benzoyl Peroxide Topical Gel 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° to 30°C (59° to 86°F). After reconstitution, store under refrigeration between 2° to 8°C (36° to 46°F). Do not freeze.
Keep tightly closed. Keep out of reach of children.
📦 Storage and Handling ▾
NOTE: Prior to reconstitution, store at room temperature between 15° to 30°C (59° to 86°F). After reconstitution, store under refrigeration between 2° to 8°C (36° to 46°F). Do not freeze. Keep tightly closed. Keep out of reach of children.
📋 Description ▾
DESCRIPTION Erythromycin-Benzoyl Peroxide Topical Gel contains erythromycin [(3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-Dideoxy-3- C -methyl-3- O -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-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.
Chemical Structure Chemical Structure
💬 Information for Patients ▾
Information for Patients: Patients using Erythromycin-Benzoyl Peroxide Topical Gel should receive the following information and instructions: 1. 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. 2. This medication should not be used for any disorder other than that for which it was prescribed.
3. Patients should not use any other topical acne preparation unless otherwise directed by their physician. 4.
Patients should report to their physician any signs of local adverse reactions. 5. Erythromycin-Benzoyl Peroxide Topical Gel may bleach hair or colored fabric.
6. Keep product refrigerated and discard after 3 months.
⚠️ Precautions ▾
PRECAUTIONS General: For topical use only; not for ophthalmic use. 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. If severe irritation develops, discontinue use and institute appropriate therapy.
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use and take appropriate measures. Avoid contact with eyes and all mucous membranes.
Information for Patients: Patients using Erythromycin-Benzoyl Peroxide Topical Gel should receive the following information and instructions: 1. 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. 2. This medication should not be used for any disorder other than that for which it was prescribed.
3. Patients should not use any other topical acne preparation unless otherwise directed by their physician. 4.
Patients should report to their physician any signs of local adverse reactions. 5. Erythromycin-Benzoyl Peroxide Topical Gel may bleach hair or colored fabric.
6. Keep product refrigerated and discard after 3 months. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter.
The clinical significance of this is unknown. No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity.
There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Erythromycin-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin-Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin-Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed.
Nursing Women: It is not known whether Erythromycin-Benzoyl Peroxide Topical Gel 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.
Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
🍼 Nursing Mothers ▾
Nursing Women: It is not known whether Erythromycin-Benzoyl Peroxide Topical Gel 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown. No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin.
However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 46.6 gram Carton NDC 68682-901-46 Rx only Erythromycin-Benzoyl Peroxide Topical Gel FOR TOPICAL USE ONLY One 46.6 g Jar (as dispensed) OCEANSIDE PHARMACEUTICALS Carton 46.6 g gel.jpg
PRINCIPAL DISPLAY PANEL - 23.3 gram Carton NDC 68682-900-23 Rx only Erythromycin-Benzoyl Peroxide Topical Gel FOR TOPICAL USE ONLY One 23.3 g Jar (as dispensed) OCEANSIDE PHARMACEUTICALS Carton 23.3 g gel.jpg
PRINCIPAL DISPLAY PANEL - NDC 68682-924-08 Rx only Erythromycin Label 0.8 g erythromycin.jpg
Package/Label Display Panel NDC 68682-923-23 Rx only Erythromycin-Benzoyl Peroxide Topical Gel FOR TOPICAL USE ONLY One 23.3 g Jar (as dispensed) Label 23.3 g Jar.jpg
Package/Label Display Panel NDC 68682-925-16 Rx only Erythromycin Label 1.6 g erythromycin.jpg
Package/Label Display Panel NDC 68682-922-46 Rx only Erythromycin-Benzoyl Peroxide Topical Gel FOR TOPICAL USE ONLY One 46.6 g Jar (as dispensed) Label 46.6 g Jar.jpg
Medicaid utilization & spend
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |