Prescription medicine

Ciprofloxacin and dexamethasone First approved as Ciprodex

Ciprofloxacin and dexamethasone (Ciprodex) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $7.12 per mL (Ciproflox-dexameth ear suspension) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the ciprofloxacin and dexamethasone FDA label on DailyMed (effective January 31, 2025, Sandoz Inc); the NDA 21537 record on Drugs@FDA; every ciprofloxacin and dexamethasone label on DailyMed.

Highlights of the record

FDA label of January 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aerug

Forms and strengths

3 mg/ml / 1 mg/ml

Suspension/ drops; suspension.

On the market

Earliest approval on file: July 18, 2003 Ciprodex, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 5 first August 10, 2020; 5 with a marketed status in Drugs@FDA
Labelers listed (NDC): 12 of which 11 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $7.12 per mL Ciproflox-dexameth ear suspension
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2025 0 Class I among all firms' recalls; latest August 13, 2025
FAERS reports: 74 through July 30, 2026

What is ciprofloxacin and dexamethasone used for?

From the label: indications and usage
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. […]

Conditions named in the indications of ciprofloxacin and dexamethasone's FDA labels, with every medicine labeled for each:

Bacterial infections

FDA pharmacologic class: Corticosteroid and Fluoroquinolone Antibacterial.

Source: FDA drug label (Ciprofloxacin and Dexamethasone), Sandoz Inc, effective January 31, 2025 (SPL set 89fef4d2-7078-47f1-96bf-aca50b135a97), via openFDA; the full label on DailyMed

Is there a generic for ciprofloxacin and dexamethasone (Ciprodex)?

The FDA approved the first generic ciprofloxacin and dexamethasone on August 10, 2020. 5 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists ciprofloxacin and dexamethasone from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

2003 earliest approval on file
2020 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for ciprofloxacin and dexamethasone (Ciprodex)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.12 per mL (Ciproflox-dexameth ear suspension), down 28% from $9.90 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Ciproflox-dexameth ear suspension (generic)

$17.66

$6.95

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Ciproflox-dexameth ear suspension	Generic	$7.12 per mL	n/a	-28%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has ciprofloxacin and dexamethasone been recalled?

The FDA's Enforcement Report lists 1 recall naming ciprofloxacin and dexamethasone since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
August 13, 2025	Class II	Sandoz Inc	Temperature Abuse

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for ciprofloxacin and dexamethasone?

The FDA Adverse Event Reporting System holds 74 reports that list ciprofloxacin and dexamethasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 19 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)11
Fatigue7
Product Dose Omission Issue (a use or a product term, not a reaction)7
Dizziness (named in the label)5
Dyspnoea (named in the label)5
Headache (named in the label)5
Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)4
Nausea4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as ciprofloxacin and dexamethasone?

3 other medicines are given the same way (auricular (otic)) and in the same FDA class as ciprofloxacin and dexamethasone or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (auricular (otic))	Pharmacy cost	Shortage
Hydrocortisone and neomycin and polymyxin b	Bacterial infections	14 labelers	$5.09 per mL Neomycin-polymyxin-hc ear solution	No current entry
Colistin, hydrocortisone, neomycin and thonzonium	Bacterial infections	none listed	$21.98 per mL Cortisporin-tc ear suspension	No current entry
Ofloxacin	Bacterial infections	20 labelers	$1.04 per mL 0.3% ear drops	No current entry

Every medicine labeled for the same conditions as ciprofloxacin and dexamethasone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to ciprofloxacin and dexamethasone: 3 medicines for the same use
Other corticosteroids: the pharmacologic class, with prices and generics
Ciprofloxacin and dexamethasone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other