by Cosette Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
This is a package of hydrocortisone and acetic acid 20 mg/mL; 10 mg/mL Solution from Cosette Pharmaceuticals, Inc., marketed since Feb 2024 and currently FDA-listed; retail pharmacies pay about $5.44 per mL (NADAC). It is this product's only package size.
NDC 00713-0849-09
🏷️ FDA NDC (as labeled)0713-0849-09billing pads the labeler segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
Mechanism of actionCorticosteroid Hormone Receptor Agonists
DEA scheduleNon-controlled
Marketing categoryANDA
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2024-02-01
RouteAURICULAR (OTIC)
Dosage formSOLUTION
SubstanceACETIC ACID; HYDROCORTISONE
TE code (Orange Book)AT · RLD · RS
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-1487300020102000
GCN Seq No048554
GCN14017
HICL code003594
Ingredient (HICL)Hydrocortisone/Acetic Acid
HIC1 codeQ
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ8
Therapeutic class — intermediate (HIC2)Otic Preparations
HIC3 codeQ8B
Therapeutic class — specific (HIC3)Ear Preparations, Misc. Anti-Infectives
AHFS code52:04.92.00
AHFS classAnti-Infectives, Miscellaneous (52:04)
FDB label nameHYDROCORTISONE-ACETIC EAR DROP
FDB brand nameHydrocortisone-Acetic Acid
Legend statusF — Federal legend — prescription drug or device
Quick answers
GSN (GCN sequence number):048554
GCN:14017
GPI-14 (Medi-Span):87300020102000
HICL (First Databank):003594
AHFS class code:52:04.92.00
RxCUI (RxNorm):313786
Why two NDCs?
The FDA registers this code as 0713-0849-09 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00713-0849-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
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
$5.435
$54.35 / 10 ml
Medicaid paysCMS SDUD · 12 mo
$7.57
$75.74 / 10 ml
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 2% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable 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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
⏱️Dosage and Administration133 words▾
DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Hydrocortisone and Acetic Acid every 4 to 6 hours.
The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
⛔Contraindications35 words▾
CONTRAINDICATIONS Hypersensitivity to Hydrocortisone and Acetic Acid or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.
⚠️Warnings8 words▾
WARNINGS Discontinue promptly if sensitization or irritation occurs.
🤒Adverse Reactions32 words▾
ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧒Pediatric Use18 words▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
🧬Clinical Pharmacology39 words▾
CLINICAL PHARMACOLOGY Acetic acid is antibacterial and antifungal; hydrocortisone is anti-inflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.
📦How Supplied / Storage and Handling27 words▾
HOW SUPPLIED Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 0713-0849-09).
📋Description94 words▾
DESCRIPTION Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.0025%). The empirical formulas for acetic acid and hydrocortisone are CH 3 COOH, and C 21 H 30 O 5 , with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are: Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
Structure
⚠️Precautions38 words▾
PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear. Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
📄Package Label / Principal Display Panel42 words▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0713- 0849 -09 Rx only Hydrocortisone and Acetic Acid Otic Solution, USP 10 mL Cosette Pharmaceuticals, Inc. NDC 0713- 0849 -09 Rx only Hydrocortisone and Acetic Acid Otic Solution, USP 10 mL Cosette Pharmaceuticals, Inc. Carton Bottle
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
contraindication: A situation in which a medicine should not be used because the risk is considered too high.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.
Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.5K
Units reimbursed last 4 qtrs
35.1K
Gross reimbursed last 4 qtrs
$265.7K
Avg / prescription
$76.87
Avg / unit
$7.5743
Latest quarter Q1 2026
775Rx
Medicaid pays / mL
$7.5743
gross reimbursed
vs
NADAC / mL
$5.4354
acquisition cost
=
Spread
+$2.1389
+39% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
46% FFS54% MCO
Fee-for-service · 1,593 Rx Managed care · 1,864 Rx
State Medicaid map
Units reimbursed · per 100k residents
1.688.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Oregon88.8 /100k
2Washington65.2 /100k
3New Mexico55.8 /100k
4Arizona29.3 /100k
5Colorado27.2 /100k
6Minnesota25.6 /100k
7Missouri25.5 /100k
8California21.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hydrocortisone and Acetic Acid — the ingredient across all brands.
Top reported reactions
Asthenia5
Covid-195
Fatigue4
Pain4
Vomiting4
Abdominal Discomfort3
Fall3
Reporter sex
Serious outcomes
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
