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hydrocortisone and acetic acid 20.75 mg/mL; 10.375 mg/mL Solution — NDC 71656-064-10 (Billing 71656-0064-10)

by Saptalis Pharmaceuticals, LLC · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of hydrocortisone and acetic acid 20.75 mg/mL; 10.375 mg/mL Solution from Saptalis Pharmaceuticals, LLC, 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 71656-0064-10
🏷️ FDA NDC (as labeled) 71656-064-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ 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
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71656-064-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71656 labeler · 064 product · 10 package
Package marketed since
Feb 23, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7165606410 5
Medicaid fills, this package
3,545 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71656-064-10
Product NDC 71656-064
11-digit billing NDC 71656006410
NCPDP billing unit ML — per mL (volume)
RxCUI 313786
UNII Q40Q9N063P, WI4X0X7BPJ
Application # NDA012770
SPL Set ID d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-23
Route AURICULAR (OTIC)
Dosage form SOLUTION
Substance ACETIC ACID; HYDROCORTISONE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 87300020102000
GCN Seq No 048554
GCN 14017
HICL code 003594
Ingredient (HICL) Hydrocortisone/Acetic Acid
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q8
Therapeutic class — intermediate (HIC2) Otic Preparations
HIC3 code Q8B
Therapeutic class — specific (HIC3) Ear Preparations, Misc. Anti-Infectives
AHFS code 52:04.92.00
AHFS class Anti-Infectives, Miscellaneous (52:04)
FDB label name HYDROCORTISONE-ACETIC EAR DROP
FDB brand name Hydrocortisone-Acetic Acid
Legend status F — 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 71656-064-10 — a 5-3-2 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 product segment → 71656-0064-10. 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.

RxNorm drug class

This medicine belongs to the Organic acids class.

Drug family (ATC) Organic acids, Antiinfectives
Where does this data come from?
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.

Clinical

Label name HYDROCORTISONE-ACETIC EAR DROP Ingredient Hydrocortisone/Acetic Acid

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $5.435 $54.35 / 10 ml
Medicaid paysCMS SDUD · 12 mo $7.81 $78.10 / 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
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $6.015 $5.361
▼ 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71656-0064-10 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 2024-02-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
hydrocortisone and acetic acid 20 mg/mL; 10 mg/mL 00713-0849-09 Cosette 1 bottle $5.435 AT Availability likely —
Hydrocortisone and Acetic Acid 10.4 mg/mL; 20.8 mg/mL 51672-3007-01 Sun 1 bottle $5.435 AT Availability likely —
hydrocortisone and acetic acid 20.75 mg/mL; 10.375 mg/mLthis 71656-0064-10 Saptalis 1 bottle $5.435 AT Availability likely —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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.

Availability & generic status

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 / 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.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII PH41D05744
    A synthetic antimicrobial chemical compound used as a preservative in medicines and personal care products. It prevents bacterial and fungal growth to keep the product safe during storage and use.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 5Z492UNF9O
    A synthetic liquid derived from propylene glycol, used in medicines as a solvent and humectant to dissolve active ingredients and maintain moisture in the formulation.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
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.

Manufacturer & labeler

LabelerSaptalis Pharmaceuticals, LLC
Application holderSAPTALIS PHARMACEUTICALS LLC
FDA applicationNDA012770 (NDA AUTHORIZED GENERIC)
Labeler code71656
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio7 products on file

More NDCs from Saptalis Pharmaceuticals, LLC labeler code 71656

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.

Full prescribing information FDA SPL

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

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 Administration 133 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.

⛔ Contraindications 35 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.

⚠️ Warnings 8 words ▾

WARNINGS: Discontinue promptly if sensitization or irritation occurs.

🤒 Adverse Reactions 33 words ▾

ADVERSE REACTIONS: Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-­800-FDA-1088 or www.fda.gov/medwatch .

🧒 Pediatric Use 18 words ▾

PEDIATRIC USE: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

🧬 Clinical Pharmacology 39 words ▾

CLINICAL PHARMACOLOGY: Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, 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 Handling 27 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 71656-064-10).

📋 Description 87 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 (0.015%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, 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.

Chemical Structure_Hydrocortisone

⚠️ Precautions 38 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 Panel 50 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Carton

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
36.1K
Gross reimbursed last 4 qtrs
$281.7K
Avg / prescription
$79.45
Avg / unit
$7.8097
Latest quarter Q1 2026
1KRx
Medicaid pays / mL
$7.8097
gross reimbursed
vs
NADAC / mL
$5.4354
acquisition cost
=
Spread
+$2.3743
+44% 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 ⓘ
51% FFS 49% MCO
Fee-for-service · 1,796 Rx Managed care · 1,749 Rx
State Medicaid map
Alaska: no data reported AK Maine: 590 units · 42.3 per 100k residents ME Washington: 2,030 units · 26.0 per 100k residents WA Idaho: 160 units · 8.1 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 920 units · 16.0 per 100k residents MN Wisconsin: no data reported WI Michigan: 2,750 units · 27.4 per 100k residents MI New York: 6,280 units · 32.1 per 100k residents NY Vermont: no data reported VT New Hampshire: 300 units · 21.4 per 100k residents NH Oregon: 1,610 units · 38.0 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 1,010 units · 7.8 per 100k residents PA New Jersey: 705 units · 7.6 per 100k residents NJ Massachusetts: 5,030 units · 71.8 per 100k residents MA California: 7,550 units · 19.4 per 100k residents CA Utah: no data reported UT Colorado: 300 units · 5.1 per 100k residents CO Nebraska: no data reported NE Missouri: 340 units · 5.5 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,560 units · 17.9 per 100k residents VA Maryland: 680 units · 11.0 per 100k residents MD Connecticut: 1,160 units · 32.1 per 100k residents CT Rhode Island: no data reported RI Arizona: 710 units · 9.6 per 100k residents AZ New Mexico: 170 units · 8.0 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 630 units · 8.8 per 100k residents TN North Carolina: 130 units · 1.2 per 100k residents NC South Carolina: 670 units · 12.5 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 160 units · 3.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 620 units · 5.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.271.8
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
🏆 Top states by units · per 100k residents
1 Massachusetts 71.8 /100k
2 Maine 42.3 /100k
3 Oregon 38.0 /100k
4 New York 32.1 /100k
5 Connecticut 32.1 /100k
6 Michigan 27.4 /100k
7 Washington 26.0 /100k
8 New Hampshire 21.4 /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 (this brand).

Top reported reactions

Asthenia5
Covid-195
Fatigue4
Pain4
Vomiting4
Abdominal Discomfort3
Fall3

Age at onset

Child2
Adult5
Elderly4

Reporter sex

40 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization10
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9 0
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.
← 71656-0061-16 · Saptalis 71656-0066-20 · Saptalis →
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.