Ofloxacin 3 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Quinolone Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ofloxacin otic is used to treat outer ear infections in adults and children, chronic (long-lasting) middle ear infections in adults and children with a perforated eardrum (a condition where the eardrum has a hole in it), and acute (suddenly occurring) middle ear infections in children with ear tubes. Ofloxacin otic is in a class of medications called quinolone antibiotics. It works by killing the bacteria that cause infection.
Read the full MedlinePlus article ↗- No — please don't do that. The ear drops and eye drops are different formulations made for very different tissues. Using ear drops in your eye could cause irritation or harm. If yo...
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Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ofloxacin — tap one for details:
Ofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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 F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid 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?
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💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $2.37 | $11.84 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ofloxacin 3 mg/mL 64980-0432-01 | Rising | 1 bottle | $0.976 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 65145-0144-01 | Caplin | 1 bottle | $0.976 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 69238-1616-06 | Amneal | 1 bottle | $0.976 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 70069-0687-01 | Somerset | 1 bottle | $0.976 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 70756-0610-30 | Lifestar | 10 ml | $0.976 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 24208-0410-05 | Bausch | 1 bottle | $1.114 | AT | Availability likely | — |
| Ofloxacin Otic 3 mg/mL 60505-0363-01 | Apotex | 5 ml | $1.114 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 65145-0143-01 | Caplin | 1 bottle | $1.114 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 69238-1615-03 | Amneal | 1 bottle | $1.114 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 69315-0320-05 | Leading | 5 ml | $1.114 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 70069-0686-01 | Somerset | 1 bottle | $1.114 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 70756-0609-15 | Lifestar | 5 ml | $1.114 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 72603-0186-01 | NorthStar | 5 ml | $1.114 | AT | Availability likely | — |
| Ofloxacin Otic 3 mg/mL 50090-1090-00 | A-S | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 50090-5670-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 50090-7207-00 | A-S | 5 ml | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 63187-0184-05 | Proficient | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 63187-0472-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 63629-8716-01 | Bryant | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 67296-1925-01 | Redpharm | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 67296-2159-05 | Redpharm | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mLthis 67296-2179-05 | Redpharm | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 68071-1588-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 68071-1630-03 | NuCare | 10 ml | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 68071-3604-03 | NuCare | 10 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68788-4086-01 | Preferred | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 68788-8551-01 | Preferred | 10 ml | — | AT | Discontinued | — |
| ofloxacin 3 mg/mL 70518-3984-00 | REMEDYREPACK | 5 ml | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 70518-4226-00 | REMEDYREPACK | 5 ml | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 71335-2822-01 | Bryant | 5 ml | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 72162-1709-02 | Bryant | 5 ml | — | AT | FDA listed | — |
| Ofloxacin Otic 3 mg/mL 72189-0108-05 | DIRECT | 5 ml | — | AT | FDA listed | — |
| Olfoxacin Otic Soln 3 mg/mL 72189-0490-05 | Direct_Rx | 5 ml | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 76420-0748-05 | Asclemed | 5 ml | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 76420-0749-10 | Asclemed | 10 ml | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 82804-0061-05 | Proficient | 5 ml | — | AT | 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67296-2179-05 You're viewing this | 1 BOTTLE in 1 CARTON (67296-2179-5) / 5 mL in 1 BOTTLE | 2024-10-31 | Active |
🧭 About this NDC listing & data coverage
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) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to, Proteus mirabilis , Pseudomonas aeruginosa, and Staphylococcus aureus . Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis , Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae .
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution.
The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is: Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled.
The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.
Chronic Suppurative Otitis Media with perforated tympanic membranes: The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops.
The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.
⛔ Contraindications ▾
CONTRAINDICATIONS Ofloxacin otic solution 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
⚠️ Warnings ▾
WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin.
Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to ofloxacin is suspected, stop the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment.
Oxygen and airway management, including intubation, should be administered as clinically indicated.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Subjects with Otitis Externa In the Phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in 2 or more of the subjects: † Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative.
Adverse Event Incidence Rate Studies 002/003 † BID (N=229) Studies 016/017 † QD (N=310) Studies 020 † QD (N=489) Application Site 3% 16.8% 0.6% Reaction Pruritus 4% 1.2% 1.0% Earache 1% 0.6% 0.8% Dizziness 1% 0.0% 0.6% Headache 0% 0.3% 0.2% Vertigo 1% 0.0% 0.0% Study 020 (QD) was open and non-comparative. An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate- hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.
In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection. In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia. Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes In Phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution: Adverse Event Incidence (N=656) Taste Perversion 7% Earache 1% Pruritus 1% Paraesthesia 1% Rash 1% Dizziness 1% Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%).
The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia. Post-Marketing Adverse Events Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post- marketing reports. A causal relationship with ofloxacin otic solution 0.3% is unknown.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics : Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea, and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of ofloxacin solution. In two single-dose studies, mean ofloxacin serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of a 0.3% solution (4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively).
In adults with perforated tympanic membranes, the maximum serum drug level of ofloxacin detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacin was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 of 16 subjects). The variability of ofloxacin concentration in middle ear mucosa was high.
The concentrations ranged from 1.2 to 602 μg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 μg/g, n=13) 30 minutes after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of ofloxacin in the otorrhea does not necessarily reflect the exposure of the middle ear to ofloxacin.
Microbiology : Ofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription.
Cross-resistance has been observed between ofloxacin and other fluoroquinolones. There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections as described in the INDICATIONS AND USAGE section.
AEROBES, GRAM-POSITIVE : Staphylococcus aureus Streptococcus pneumoniae AEROBES, GRAM-NEGATIVE: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ofloxacin otic solution 0.3% is supplied in plastic dropper bottles containing 5 mL and 10 mL. NDC 70069- 686 -01 Ofloxacin Otic solution (5mL) NDC 70069- 687 -01 Ofloxacin Otic solution (10 mL) Store at 25 °C (77 °F), excursions permitted to 15°-30°C (59-86 °F). Protect from light. Rx Only Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Made in India Code No.: KR/DRUGS/KTK/28/289/97 1201075 ST-OFO/P/00 Revised: October, 2024
📋 Description ▾
DESCRIPTION Ofloxacin otic solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9- fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid.
The empirical formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.38. The structural formula is: Ofloxacin otic contains 0.3% (3mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH between 6.0 and 6.6.
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💬 Patient Medication Information ▾
PATIENT INFORMATION Ofloxacin otic solution 0.3% IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. What is ofloxacin otic solution?
Ofloxacin otic solution is an antibiotic in a sterile solution used to treat ear infections caused by certain bacteria found in: patients (12 years and older) who have a middle ear infection and have a hole in the eardrum pediatric patients (between 1 and 12 years of age) who have a middle ear infection and have a tube in the eardrum patients (6 months and older) who have an infection in the ear canal. Middle Ear Infection: A middle ear infection is a bacterial infection behind the eardrum. People with a hole or a tube in the eardrum may notice a discharge (fluid draining) from the ear canal.
Ear Canal Infection: An ear canal infection (also known as "Swimmer's Ear") is a bacterial infection of the ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.
Who should NOT use ofloxacin otic solution? Do not use this product if you are allergic to ofloxacin or to other quinolone antibiotics. Do not give this product to pediatric patients who: have an ear canal infection and are less than 6 months of age because no data were collected from this population have a middle ear infection and have a tube in the eardrum and are less than one year of age because no data were collected from this population have a middle ear infection and have a hole in the eardrum and are less than 12 years of age because no data were collected from this population.
How should ofloxacin otic solution be given? 1. Wash hands The person giving ofloxacin otic solution should wash his/her hands with soap and water.
2. Clean ear & warm bottle Gently clean any discharge that can be removed easily from the outer ear. DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL.
Hold the bottle of ofloxacin otic solution in the hand for one or two minutes to warm the solution. 3. Add drops For a Middle Ear Infection: The person receiving ofloxacin otic solution should lie on his/her side with the infected ear up.
Patients (12 and older) should have 10 drops of ofloxacin otic solution put into the infected ear. Pediatric patients under 12 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces.
For an Ear Canal Infection ("Swimmer's Ear"): The person receiving ofloxacin otic solution should lie on his/her side with the infected ear up. Patients (13 and older) should have 10 drops of ofloxacin otic solution put into the infected ear. Pediatric patients under 13 should have 5 drops put into the infected ear.
The tip of the bottle should not touch the fingers or the ear or any other surfaces. BE SURE TO FOLLOW THE INSTRUCTIONS BELOW FOR THE PATIENT'S SPECIFIC EAR INFECTION. 4.
Press ear or pull ear For a Middle Ear Infection: While the person receiving ofloxacin otic solution lies on his/her side, the person giving the drops should gently press the TRAGUS (see diagram) 4 times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear. For an Ear Canal Infection ("Swimmer's Ear"): While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear upward and backward.
This will allow the ear drops to flow down into the ear canal. The person who received the ear drops should remain on his/her side for at least 5 minutes. Repeat Steps 2-5 for the other ear if both ears are infected.
How often should ofloxacin otic solution be given? In patients with an Ear Canal Infection ("Swimmer's Ear"), ofloxacin otic solution ear drops should be given once daily at about the same time each day (for example, 8 AM or 8 PM) in each infected ear unless the doctor has instructed otherwise. In patients with a Middle Ear Infection, ofloxacin otic solution ear drops should be given 2 t…