Olfoxacin Otic Soln 3 mg/mL Solution, 5 mL
🆔 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
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🩺 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
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🧪 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
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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/mL 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/mLthis 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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72189-0490-05 You're viewing this | 5 mL in 1 BOTTLE, DROPPER (72189-490-05) | 2023-06-08 | 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
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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 ▾
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 and 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 ▾
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 which 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 ▾
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 ▾
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 ▾
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 two or more of the subjects: Adverse Event Incidence Rate Studies 002/003† BID (N=229) Studies 016/017† QD (N=310) Study 020† QD (N=489) Application Site Reaction 3% 16.8% 0.6% 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% † Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧬 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 mcg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 mcg/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.
Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus Streptococcus pneumoniae Aerobic and facultative gram-negative microorganisms: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa
📦 How Supplied / Storage and Handling ▾
Ofloxacin Otic Solution 0.3% is supplied in plastic dropper bottles in the following sizes: NDC 72189-490-05 5 mL NDC 70756-610-30 10 mL
📦 Storage and Handling ▾
Storage: Store at 20º to 25°C (68º to 77°F). [See USP Controlled Room Temperature.] Protect from light.
📋 Description ▾
Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) 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 molecular formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is: Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.