Ciprofloxacin and Hydrocortisone Otic
Ciprofloxacin and hydrocortisone otic suspension is an antibiotic-plus-steroid ear drop combination used to treat acute otitis externa (swimmer's ear) in adults and children one year and older.
🧬 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 7 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 →
📖 Ciprofloxacin and Hydrocortisone Otic: Patient Information Guide
A plain-language walkthrough of Ciprofloxacin and Hydrocortisone Otic — 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▾
Ciprofloxacin and hydrocortisone otic suspension is approved to treat a specific ear infection in adults and children.
- Acute otitis externa (swimmer's ear) — in adults and pediatric patients one year and older, caused by susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, or Proteus mirabilis
⚙️How it works▾
Ciprofloxacin is a fluoroquinolone antibiotic that kills bacteria by blocking DNA gyrase — an enzyme bacteria must have to replicate their DNA. Without this enzyme, bacteria cannot reproduce, and the infection clears. Hydrocortisone is a corticosteroid added to reduce the inflammation (redness, swelling, pain) that comes along with the bacterial infection.
Because these drops are applied directly into the ear canal, the amount absorbed into the bloodstream is extremely small — too low to even measure reliably. Cross-resistance can occur between ciprofloxacin and other fluoroquinolones, but generally not between ciprofloxacin and unrelated antibiotic classes such as beta-lactams or aminoglycosides.
💊How it's taken▾
The suspension is placed directly into the affected ear canal — it is not taken by mouth and is not for injection or eye use. The usual course is twice daily for seven days for both adults and children one year and older.
- Shake the bottle well right before each use
- Warm the bottle in your hand for 1–2 minutes before instilling drops to avoid dizziness
- Lie with the affected ear up; keep that position for 30–60 seconds after the drops go in
- Discard unused drops when your treatment course is done
🤒Side effects — in detail▾
Most side effects with these ear drops are mild. Reported effects include:
- Headache
- Itching (pruritus)
- Dizziness
- Redness of the ear canal
- Ear congestion
- Reduced hearing (hypoacusis)
- Medication residue in the ear
- Rash or hives (uncommon)
Stop using immediately and seek emergency care if you develop a rash, hives, or any signs of a serious allergic reaction — severe reactions, including anaphylaxis, have been reported with quinolone antibiotics.
⚠️Warnings & precautions▾
The most critical risk is a serious allergic (hypersensitivity) reaction, which can happen even after the first dose. Signs include rash, hives, swelling, or difficulty breathing. Stop the drops and get emergency help right away if this happens. The dropper cap contains natural rubber latex, which can trigger severe reactions in people with latex allergies.
- For ear use only — not for eyes, not for injection
- Do not use if the eardrum is perforated (has a hole) — this is a non-sterile product and could cause harm
- Do not use for viral ear canal infections (such as herpes simplex or chickenpox/varicella)
- Discontinue at the first sign of rash or allergic reaction
🔀What it interacts with▾
The FDA label for this product does not describe specific drug, food, or supplement interactions for the otic (ear) formulation.
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 if you are allergic to ciprofloxacin, hydrocortisone, or any quinolone antibiotic
- Do not use if your eardrum is known or suspected to be ruptured (perforated)
- Do not use for viral ear infections such as herpes simplex or varicella (chickenpox)
- Tell your doctor if you have a latex allergy — the dropper cap contains natural rubber
- Not approved for use in children under one year of age
📡Pharmacodynamics — effects in the body▾
Ciprofloxacin is active against a broad range of gram-positive and gram-negative bacteria by interfering with DNA gyrase, which bacteria need to synthesize DNA. Hydrocortisone helps resolve inflammation in the ear canal that accompanies the bacterial infection. Preclinical studies showed the suspension was not toxic to the cochlea (the hearing organ) when given twice daily for 30 days in animal models.
🔬Pharmacokinetics — how your body processes it▾
When applied as ear drops, systemic (whole-body) absorption of ciprofloxacin is expected to be below the level that can be reliably detected in the blood. The amount of hydrocortisone absorbed is similarly too small to distinguish from the body's own natural cortisol levels. This means the medication works locally in the ear with minimal whole-body exposure.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) . Avoid freezing. Protect from light.
📄 Written from Ciprofloxacin and Hydrocortisone Otic’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 Ciprofloxacin and Hydrocortisone Otic — the kind of thing our pharmacy team would talk through with you at the counter.
What is this ear drop actually treating? ▾
How do I put the drops in correctly? ▾
What side effects should I watch out for? ▾
I have a latex allergy — is it safe for me to use this? ▾
Do I need to finish the full 7 days even if my ear feels better sooner? ▾
Can I use these drops if I think my eardrum might be ruptured? ▾
Is Ciprofloxacin and Hydrocortisone Otic available over the counter? ▾
When was Ciprofloxacin and Hydrocortisone Otic first available? ▾
Who makes Ciprofloxacin and Hydrocortisone Otic? ▾
💬 Answers drafted from Ciprofloxacin and Hydrocortisone Otic’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 Ciprofloxacin and Hydrocortisone Otic comes
Ciprofloxacin and Hydrocortisone Otic 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.
Ear drops
How this form is used
- Treats acute otitis externa (swimmer's ear) caused by susceptible bacteria in adults and children one year and older
- Shake the bottle well immediately before each use
- Warm the bottle by holding it in your hand for 1–2 minutes before instilling drops — cold drops can cause dizziness
- Lie with the affected ear facing up, instill the drops, and remain in that position for 30–60 seconds
- Discard any unused suspension when the full course of treatment is complete
📊 Ciprofloxacin and Hydrocortisone Otic across the U.S. market
How Ciprofloxacin and Hydrocortisone Otic 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ciprofloxacin and Hydrocortisone Otic is used
A general measure of how commonly Ciprofloxacin and Hydrocortisone Otic 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 Ciprofloxacin and Hydrocortisone Otic 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.
How commonly is Ciprofloxacin and Hydrocortisone Otic prescribed? Of the 1,596 medications we measure, Ciprofloxacin and Hydrocortisone Otic ranks #815 by Medicaid prescriptions — more than 49% of them.
Utilization by Ciprofloxacin and Hydrocortisone Otic 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 Ciprofloxacin and Hydrocortisone Otic products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 8 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 Ciprofloxacin and Hydrocortisone Otic, 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 2 of 8 listed Ciprofloxacin and Hydrocortisone Otic NDCs with Medicaid activity.
🔍 Compare Ciprofloxacin and Hydrocortisone Otic products
A representative set of FDA-listed product records for Ciprofloxacin and Hydrocortisone Otic — 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 |
|---|---|---|---|---|
| 💊Ear drops | ||||
| CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL; HYDROCORTISONE 10 mg/mL | Auricular (otic) | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| 2; 10 mg/mL; mg/mL | Auricular (otic) | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| 2; 10 mg/mL; mg/mL | Auricular (otic) | Alcon Laboratories, Inc. | NDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL; HYDROCORTISONE 10 mg/mL | Auricular (otic) | Asclemed USA, Inc. | NDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL; HYDROCORTISONE 10 mg/mL | Auricular (otic) | Cosette Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2; 10 mg/mL; mg/mL | Auricular (otic) | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL; HYDROCORTISONE 10 mg/mL | Auricular (otic) | Sandoz Inc | NDA | View NDC → |
| CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL; HYDROCORTISONE 10 mg/mL | Auricular (otic) | Sandoz Inc | NDA AUTHORIZED GENERIC | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Ciprofloxacin and Hydrocortisone Otic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ciprofloxacin and Hydrocortisone Otic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ciprofloxacin and Hydrocortisone Otic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ciprofloxacin and Hydrocortisone Otic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Ciprofloxacin and Hydrocortisone Otic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ciprofloxacin and Hydrocortisone Otic belongs to the Fluoroquinolone Antibacterial class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 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. Sandoz 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.