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ACETIC ACID 20 mg/mL Solution, 15 mL — NDC 62135-801-51 (Billing 62135-0801-51)

by Chartwell RX, LLC · 15 mL in 1 BOTTLE

This is a package of 15 mL of ACETIC ACID 20 mg/mL Solution from Chartwell RX, LLC, marketed since Jul 1996 and currently FDA-listed; retail pharmacies pay about $1.49 per mL (NADAC). It is this product's only package size.

NDC 62135-0801-51
🏷️ FDA NDC (as labeled) 62135-801-51 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 →

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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 62135-801-51 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62135 labeler · 801 product · 51 package
Package marketed since
Mar 25, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
15 mL per package
Barcode (UPC)
0362135801519
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-801-51
Product NDC 62135-801
11-digit billing NDC 62135080151
NCPDP billing unit ML — per mL (volume)
RxCUI 197305
UNII Q40Q9N063P
UPC 0362135801519
Application # ANDA040166
SPL Set ID 2aaf3781-4f25-4799-8dcd-78d67e226ccc
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-07-26
Route AURICULAR (OTIC)
Dosage form SOLUTION
Substance ACETIC ACID

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

GPI-14 87400010102010
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 62135-801-51 — 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 → 62135-0801-51. 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 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 $1.44 $21.60 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.561 $1.438
▼ Down 5% 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
62135-0801-51 You're viewing this Main listing 15 mL in 1 BOTTLE 2024-03-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetic Acid 20.65 mg/mL 52817-0816-15 TruPharma, 1 bottle $1.490 AT Availability likely —
Acetic Acid 20 mg/mLthis 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

🏛️
1996
On the market since
Jul 1996
📍
2026
Currently FDA-listed
30 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

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA040166 (ANDA)
Labeler code62135
First marketedJul 1996
Product typeHuman Prescription Drug
Portfolio521 products on file

More NDCs from Chartwell RX, LLC labeler code 62135

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 🧬 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 129 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 the 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 to 5 drops of the solution every 4 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 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 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 15 words ▾

ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

🧬 Clinical Pharmacology 33 words ▾

CLINICAL PHARMACOLOGY Acetic acid is anti-bacterial and anti-fungal; 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 40 words ▾

HOW SUPPLIED Acetic Acid Otic Solution, USP, 2% is a colorless to pale yellow color solution supplied in 15 mL bottle with dropper plug and extended TIP closure. They are available as follows: Bottle of 15 mL – NDC 62135-801-51

📦 Storage and Handling 32 words ▾

RECOMMENDED STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP CONTAINER TIGHTLY CLOSED Rx Only Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71805 Rev: 03/2024

📋 Description 87 words ▾

DESCRIPTION Acetic Acid Otic Solution, USP is a colorless to pale yellow color nonaqueous solution of glacial acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride, propylene glycol diacetate, and sodium acetate trihydrate. It may also contain citric acid anhydrous. 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. image description

⚠️ 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 19 words ▾

PRINCIPAL DISPLAY PANEL Acetic Acid Otic Solution, USP 2% - NDC 62135-801-51 - 15 mL Bottle Label image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.
← 62135-0800-60 · Chartwell 62135-0802-53 · Chartwell →
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.