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erythromycin
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Erythromycin | 20 mg/mL | 197650 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Sebaceous Gland Activity [PE] | PE | All 37 members |
| Macrolide Antimicrobial [EPC] | EPC | All 31 members |
| Macrolide [EPC] | EPC | All 16 members |
| Macrolides [CS] | CS | All 32 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 063038-001 | ERYTHROMYCIN | SOLUTION | ERYTHROMYCIN | Prescription | AT | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 4 | Labeling | Approved | April 24, 2014 | — |
| Supplement | 1 | Labeling | Approved | January 10, 1992 | — |
| Original application | 1 | Approved | January 11, 1991 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241011). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Erythromycin Topical Solution USP, 2% should be applied over the affected areas twice a day (morning and evening) after the skin is thoroughly washed with warm water and soap and patted dry. Acne lesions on the face, neck, shoulders, chest, and back may be treated in this manner. This medication should be applied with applicator top. If fingertips are used, wash hands after application. Drying and peeling may be controlled by reducing the frequency of applications.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Erythromycin Topical Solution USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings
openFDA Drug LabelingWARNINGS 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
openFDA Drug LabelingADVERSE REACTIONS The following local adverse reactions have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with topical use of erythromycin. Generalized urticarial reactions possibly related to the use of erythromycin, which required systemic steroid therapy have been reported.
Description
openFDA Drug LabelingDESCRIPTION Erythromycin Topical Solution USP, 2% contains erythromycin for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus ). It is a base and readily forms salts with acids. Chemically, erythromycin is: (3 R *,4 S *,5 S *,6 R *,7 R *,9 R *,11 R *,12 R *,13 S *,14 R *)-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)-ß-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following structural formula: Molecular Formula: C 37 H 67 NO 13 Molecular Weight: 733.94 Erythromycin is a white or slightly yellow crystalline powder that is slightly soluble in water, freely soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene dichloride and amyl acetate. Each mL of Erythromycin Topical Solution USP, 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (66%), citric acid, and propylene glycol. Structural Formula
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Erythromycin Topical Solution USP, 2% is available as follows: 60 mL bottle with applicator (NDC 72162-2075-6) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ERYTHROMYCIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 72162-2075-6 | 72162-2075 | Bryant Ranch Prepack | 1 BOTTLE in 1 CARTON (72162-2075-6) / 60 mL in 1 BOTTLE | August 16, 2023 |
| 68071-4791-6 | 68071-4791 | NuCare Pharmaceuticals,Inc. | 60 mL in 1 BOTTLE (68071-4791-6) | March 4, 2019 |
| 45802-038-46 | 45802-038 | Padagis Israel Pharmaceuticals Ltd | 1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE | December 19, 2011 |
| 72162-2075 | 72162-2075 | Bryant Ranch Prepack | — | December 19, 2011 |
| 68071-4791 | 68071-4791 | NuCare Pharmaceuticals,Inc. | — | December 19, 2011 |
| 45802-038 | 45802-038 | Padagis Israel Pharmaceuticals Ltd | — | December 19, 2011 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.