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Acetic Acid 20.65 mg/mL Solution — NDC 52817-816-15 (Billing 52817-0816-15)

by TruPharma, LLC · 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of Acetic Acid 20.65 mg/mL Solution from TruPharma, LLC, marketed since Jun 2020 and currently FDA-listed; retail pharmacies pay about $1.49 per mL (NADAC). It is this product's only package size.

NDC 52817-0816-15
🏷️ FDA NDC (as labeled) 52817-816-15 billing pads the product segment with a zero
Rx only Generic 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 52817-816-15 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
52817 labeler · 816 product · 15 package
Package marketed since
Jun 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5281781615 3
Medicaid fills, this package
23,179 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) 52817-816-15
Product NDC 52817-816
11-digit billing NDC 52817081615
NCPDP billing unit ML — per mL (volume)
RxCUI 197305
UNII Q40Q9N063P
Application # ANDA040607
SPL Set ID 0c5ebd59-0e98-4ea1-b279-9202a19f6dbf
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-01
Route AURICULAR (OTIC)
Dosage form SOLUTION
Substance ACETIC ACID
TE code (Orange Book) AT · RLD · RS

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

GPI-14 87400010102010
GPI class Acetic Acid
GCN Seq No 008101
GCN 34341
HICL code 003597
Ingredient (HICL) 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 ACETIC ACID 2% EAR SOLUTION
FDB brand name Acetic Acid
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008101
  • GCN: 34341
  • GPI-14 (Medi-Span): 87400010102010
  • HICL (First Databank): 003597
  • AHFS class code: 52:04.92.00
  • RxCUI (RxNorm): 197305
Why two NDCs? The FDA registers this code as 52817-816-15 — 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 → 52817-0816-15. 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 ACETIC ACID 2% EAR SOLUTION Ingredient 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 $1.490 $22.35 / 15 ml
Medicaid paysCMS SDUD · 12 mo $1.78 $26.70 / 15 ml
Medicare drug plans payPart D · Q2 2026 $1.44 $21.60 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.583 $1.303
▲ Up 3% over the last 24 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
52817-0816-15 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE 2020-06-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetic Acid 20.65 mg/mLthis 52817-0816-15 TruPharma, 1 bottle $1.490 AT Availability likely —
Acetic Acid 20 mg/mL 62135-0801-51 Chartwell 15 ml $1.490 — Availability likely —
Acetic Acid 20.65 mg/mL 50090-6527-00 A-S 1 bottle — AT FDA listed —
Acetic Acid 20.65 mg/mL 68071-1739-05 NuCare 15 ml — — FDA listed —
Acetic Acid 20.65 mg/mL 68071-2984-05 NuCare 1 bottle — AT FDA listed —
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.

Availability & generic status

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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 / 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

LabelerTruPharma, LLC
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA040607 (ANDA)
Labeler code52817
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio43 products on file

More NDCs from TruPharma, LLC labeler code 52817

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 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 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.

⏱️ Dosage and Administration 137 words ▾

DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow acetic acid otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid otic solution 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 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours.

The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal.

⛔ Contraindications 30 words ▾

CONTRAINDICATIONS Hypersensitivity to acetic acid otic solution or any of the ingredients. 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 32 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 1­800-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 33 words ▾

CLINICAL PHARMACOLOGY Acetic acid is antibacterial and antifungal; 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 25 words ▾

HOW SUPPLIED Acetic acid otic solution, USP, containing 2% acetic acid, is available in 15 mL measured‑drop, safety-tip plastic bottles. NDC 52817-816-15 15 mL Bottle

📦 Storage and Handling 35 words ▾

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev. 03/20-R1

📋 Description 77 words ▾

DESCRIPTION Acetic acid otic solution, USP is a solution of acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid. The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic acid otic solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

Chemical Structure

⚠️ Precautions 20 words ▾

PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

📄 Package Label / Principal Display Panel 34 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 52817-816-15 Acetic Acid Otic Solution USP, 2% Rx only 15 mL Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 52817-816-15 Acetic Acid Otic Solution USP, 2% Rx only 15 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
23.2K
Units reimbursed last 4 qtrs
354K
Gross reimbursed last 4 qtrs
$630.2K
Avg / prescription
$27.19
Avg / unit
$1.7803
Latest quarter Q1 2026
5.2KRx
Medicaid pays / mL
$1.7803
gross reimbursed
vs
NADAC / mL
$1.4902
acquisition cost
=
Spread
+$0.2901
+19% 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% FFS 54% MCO
Fee-for-service · 10,715 Rx Managed care · 12,464 Rx
State Medicaid map
Alaska: 495 units · 67.5 per 100k residents AK Maine: 1,035 units · 74.2 per 100k residents ME Washington: 5,785 units · 74.1 per 100k residents WA Idaho: 915 units · 46.6 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,325 units · 40.5 per 100k residents MN Wisconsin: 3,880 units · 65.7 per 100k residents WI Michigan: 11,015 units · 110 per 100k residents MI New York: 41,000 units · 209 per 100k residents NY Vermont: 360 units · 55.6 per 100k residents VT New Hampshire: no data reported NH Oregon: 4,930 units · 116 per 100k residents OR Nevada: 2,060 units · 64.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,655 units · 82.8 per 100k residents IA Illinois: 8,550 units · 68.1 per 100k residents IL Indiana: 6,191 units · 90.2 per 100k residents IN Ohio: 10,800 units · 91.6 per 100k residents OH Pennsylvania: 7,350 units · 56.7 per 100k residents PA New Jersey: 8,325 units · 89.6 per 100k residents NJ Massachusetts: 4,369 units · 62.4 per 100k residents MA California: 91,294 units · 234 per 100k residents CA Utah: no data reported UT Colorado: 2,040 units · 34.7 per 100k residents CO Nebraska: 1,110 units · 56.1 per 100k residents NE Missouri: 3,400 units · 54.9 per 100k residents MO Kentucky: 4,175 units · 92.2 per 100k residents KY West Virginia: 3,420 units · 193 per 100k residents WV Virginia: 5,345 units · 61.3 per 100k residents VA Maryland: 5,039 units · 81.5 per 100k residents MD Connecticut: 4,995 units · 138 per 100k residents CT Rhode Island: 1,140 units · 104 per 100k residents RI Arizona: 8,100 units · 109 per 100k residents AZ New Mexico: 3,340 units · 158 per 100k residents NM Kansas: 990 units · 33.7 per 100k residents KS Arkansas: 1,245 units · 40.6 per 100k residents AR Tennessee: 3,495 units · 49.0 per 100k residents TN North Carolina: 6,139 units · 56.7 per 100k residents NC South Carolina: 1,855 units · 34.5 per 100k residents SC Delaware: no data reported DE Oklahoma: 3,735 units · 92.2 per 100k residents OK Louisiana: 5,145 units · 112 per 100k residents LA Mississippi: 1,440 units · 49.0 per 100k residents MS Alabama: 1,135 units · 22.2 per 100k residents AL Georgia: 5,336 units · 48.4 per 100k residents GA D.C.: 210 units · 30.9 per 100k residents DC Hawaii: 2,343 units · 163 per 100k residents HI Texas: 22,000 units · 72.1 per 100k residents TX Florida: 19,891 units · 88.0 per 100k residents FL
Units reimbursed · per 100k residents
22.2234
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 California 234 /100k
2 New York 209 /100k
3 West Virginia 193 /100k
4 Hawaii 163 /100k
5 New Mexico 158 /100k
6 Connecticut 138 /100k
7 Oregon 116 /100k
8 Louisiana 112 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetic Acid — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$497.9K
Claims incl. refills
23.7K
Beneficiaries
15.3K
Spend / beneficiary
$32.49
Spend / claim
$21.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Acetic Acid — the ingredient across all brands.

Top reported reactions

Nausea38
Diarrhoea29
Toxicity To Various Agents29
Pain27
Cough25
Dyspnoea25
Arthralgia21

Age at onset

Neonate1
Child2
Adolescent2
Adult33
Elderly30

Reporter sex

384 reports
Male · 34%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization135
Disabling19
Life-threatening5
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 46 20
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.
← 52817-0815-08 · TruPharma 52817-0817-01 · TRUPHARMA, →
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.