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fluocinolone acetonide .11 mg/mL Oil — NDC 68462-0185-56 package photo

fluocinolone acetonide .11 mg/mL Oil

by Glenmark Pharmaceuticals Inc., USA · 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER
NDC 68462-0185-56
🏷️ FDA NDC (as labeled) 68462-185-56 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 30, 2025 — Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0256-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Jan 4, 2024 · Terminated — Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0259-2024

🆔 Identity & classification

FDA NDC (as labeled) 68462-185-56
Product NDC 68462-185
11-digit billing NDC 68462018556
NCPDP billing unit ML — per mL (volume)
RxCUI 1191299
UNII 0CD5FD6S2M
Application # ANDA211815
SPL Set ID a00224b0-3db5-4d40-b370-5ec5476e1e10
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-18
Route AURICULAR (OTIC)
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE
GPI-14 87300018101720
GPI class Fluocinolone Acetonide
GCN Seq No 060055
GCN 26056
HICL code 033338
Ingredient (HICL) Fluocinolone Acetonide Oil
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 Q8P
Therapeutic class — specific (HIC3) Ear Preparations Anti-Inflammatory
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name FLUOCINOLONE OIL 0.01% EAR DRP
FDB brand name Fluocinolone Acetonide Oil
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68462-185-56 — 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 → 68462-0185-56. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, Corticosteroids, potent (group III), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
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.

🏭 Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA211815 (ANDA)
Labeler code68462
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio343 products on file
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.

🩺 Clinical

Label name FLUOCINOLONE OIL 0.01% EAR DRP Ingredient Fluocinolone Acetonide Oil
📗 Our plain-language guide HelloPharmacist
  • It depends on the form you have. The topical oil, cream, and ointment forms treat skin inflammation — especially eczema (atopic dermatitis) — and other itchy or inflamed skin condi...
  • What is fluocinolone acetonide actually used for?
  • Tilt your head so the affected ear is pointing up, then gently pull your earlobe back and upward. Apply 5 drops and stay in that position for about a minute — this lets the oil wor...
  • Yes — don't apply it to your face, armpits, or groin unless your doctor specifically tells you to. Also avoid the diaper area in babies. These are sensitive spots where steroid abs...
📖 Read our full Fluocinolone guide →

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.

🧪 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII 7L6R1SQ6M0
    Oleth-2 is a synthetic chemical made by combining ethylene oxide with oleyl alcohol. It works as an emulsifier and surfactant, helping mix oil and water-based ingredients together in medicines and allowing better absorption through the skin.
  • UNII 5TL50QU0W4
    Peanut oil is a plant-based oil extracted from peanuts. It's used in medicines as a solvent and carrier to dissolve or suspend active ingredients, making them easier to deliver and absorb in the body.

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.

💲 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 $1.320 $26.39 / 20 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 · 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 2021 Apr 2022 Sep 2022 Feb 2024 $2.093 $1.221
▼ Down 28% over the last 15 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluocinolone Acetonide .11 mg/mL 45802-0009-10 Padagis 1 bottle $0.953 AT Availability likely save 28%
Fluocinolone Acetonide Oil .11 mg/mL 64980-0329-20 Rising 20 ml $0.953 AT Availability likely save 28%
Fluocinolone Acetonide .11 mg/mL 70752-0159-20 Quagen 1 bottle $0.953 AT Availability likely save 28%
Dermotic .11 mg/mL 68791-0103-20 Royal 1 bottle $1.124 AT Availability likely save 15%
Flac Otic Oil .11 mg/mL 39328-0079-20 Patrin 1 bottle $1.319 AT FDA listed —
fluocinolone acetonide .11 mg/mLthis 68462-0185-56 Glenmark 1 bottle $1.319 — FDA listed —
Fluocinolone Acetonide .11 mg/mL 71335-2879-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 72162-2320-02 Bryant 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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.

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

Medicare Part D (outpatient prescription) spending for Fluocinolone Acetonide — the program that covers self-administered drugs. 8 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 Fluocinolone Acetonide. 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
$1.68M
Claims incl. refills
37.9K
Beneficiaries
30.7K
Spend / beneficiary
$54.73
Spend / claim
$44.40
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68462-0185-56 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER 2018-12-18 Active

📄 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 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 34 words ▾

INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

⏱️ Dosage and Administration 113 words ▾

DOSAGE AND ADMINISTRATION For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil, 0.01% (ear drops) into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil, 0.01% (ear drops) into the ear.

Keep head tilted for about a minute to allow fluocinolone acetonide oil, 0.01% (ear drops) to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

⛔ Contraindications 35 words ▾

CONTRAINDICATIONS Fluocinolone acetonide oil, 0.01% (ear drops) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (See PRECAUTIONS ).

🤒 Adverse Reactions 85 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%.

🤰 Pregnancy 87 words ▾

Pregnancy Teratogenic effects: Pregnancy category C: Teratogenic effects: Pregnancy category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide oil, 0.01% (ear drops).

Therefore, fluocinolone acetonide oil, 0.01% (ear drops) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use: Fluocinolone acetonide oil, 0.01% (ear drops) may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis. Fluocinolone acetonide oil, 0.01% (ear drops) is not recommended for use on the face (See ADVERSE REACTIONS section). Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids.

They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS ).

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Fluocinolone acetonide oil, 0.01% (ear drops) is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone acetonide oil, 0.01% (ear drops) for peanut-sensitive individuals.

🆘 Overdosage 22 words ▾

OVERDOSAGE Topically applied fluocinolone acetonide oil, 0.01% (ear drops) can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).

🧬 Clinical Pharmacology 161 words ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier.

Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone acetonide oil, 0.01% (ear drops) is in the low to medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 85 words ▾

HOW SUPPLIED Fluocinolone Acetonide Oil, 0.01% (Ear Drops) is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 68462-185-56). Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CAUTION: Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa October 2018 glenmark-logo

📦 Storage and Handling 60 words ▾

Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa October 2018 glenmark-logo

📋 Description 130 words ▾

DESCRIPTION Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide, USP is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49.

It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure.jpg

💬 Information for Patients 109 words ▾

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external ear use only.

Do not use occlusive dressings. 2. Avoid contact with the eyes.

In case of contact, wash eyes liberally with water. 3. This medication should not be used for any disorder other than that for which it was prescribed.

4. Patients should promptly report to their physician any worsening of their skin condition. 5.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68462-0184-49 · GLENMARK 68462-0188-01 · Glenmark →
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.