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Fluocinolone Acetonide .11 mg/118.28mL Oil, 1 bottle — NDC 65162-703-86 (Billing 65162-0703-86)

by Amneal Pharmaceuticals LLC · 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE

This is a package of 1 bottle of Fluocinolone Acetonide .11 mg/118.28mL Oil from Amneal Pharmaceuticals LLC, no longer marketed (first marketed Sep 2015), no longer in the FDA NDC Directory; retail pharmacies pay about $0.2218 per mL (NADAC). It is this product's only package size.

NDC 65162-0703-86
🏷️ FDA NDC (as labeled) 65162-703-86 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65162-703-86
Product NDC 65162-703
11-digit billing NDC 65162070386
NCPDP billing unit ML — per mL (volume)
Application # ANDA201759
SPL Set ID 1fbfde64-a91e-412a-94b8-715248108c47
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2025)
Marketing start 2015-09-22
Route TOPICAL
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE

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

GPI-14 90550055101714
GPI class Fluocinolone Acetonide Scalp
GCN Seq No 058950
GCN 24484
HICL code 032834
Ingredient (HICL) Fluocinolone/Shower Cap
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name FLUOCINOLONE 0.01% SCALP OIL
FDB brand name Fluocinolone Acetonide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058950
  • GCN: 24484
  • GPI-14 (Medi-Span): 90550055101714
  • HICL (First Databank): 032834
  • AHFS class code: 84:06.08.00
Why two NDCs? The FDA registers this code as 65162-703-86 — 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 → 65162-0703-86. 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.

Clinical

Label name FLUOCINOLONE 0.01% SCALP OIL Ingredient Fluocinolone/Shower Cap
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Creams, ointments and solutions calm itchy, inflamed skin. The oils treat atopic dermatitis or, for ear oil, chronic eczematous external otitis. Eye impl...
  • Use the smallest amount that covers the area. Creams and ointments are usually a thin film a few times a day, and the oils follow their own schedule. If there's no improvement in 2...
  • Tilt your head, gently pull your ear lobe back and up, and use the dropper to put in 5 drops. Stay tilted for about a minute, then pat away extra oil with a cotton ball. It's usual...
  • Not the oil, unless your provider tells you to. Skin folds, armpits and groin carry a higher risk of side effects. Keep it out of your eyes, mouth and vagina.
📖 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.

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 $0.222 $26.23 / 118.28 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 $0.302 $0.200
▼ Down 27% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65162-0703-86 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE 2015-09-22 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluocinolone acetonide .01 mg/100mL 45802-0485-26 Padagis 1 bottle $0.171 AT Availability likely save 23%
Fluocinolone Acetonide .11 mg/118.28mL 51672-1357-08 Sun 1 bottle $0.171 AT Availability likely save 23%
FLUOCINOLONE ACETONIDE Oil .11 mg/mL 64980-0330-04 RISING 118.28 ml $0.171 AT Availability likely save 23%
Fluocinolone Acetonide .11 mg/mL 70752-0158-06 Quagen 1 bottle $0.171 AT Availability likely save 23%
fluocinolone acetonide .01 mg/100mL 45802-0887-26 Padagis 1 bottle $0.175 AT Availability likely save 21%
Fluocinolone Acetonide .11 mg/118.28mL 51672-1356-08 Sun 1 bottle $0.175 AT Availability likely save 21%
Fluocinolone Acetonide Oil .11 mg/mL 64980-0331-04 Rising 118.28 ml $0.175 AT Availability likely save 21%
Fluocinolone Acetonide .11 mg/mL 70752-0156-06 Quagen 1 bottle $0.175 AT Availability likely save 21%
Fluocinolone Acetonide .11 mg/118.28mLthis 65162-0703-86 Amneal 1 bottle $0.222 — Discontinued —
Fluocinolone Acetonide .11 mg/mL 68462-0590-89 Glenmark 1 bottle $0.222 — FDA listed —
Derma-Smoothe/Fs .11 mg/mL 68791-0102-04 Royal 1 bottle $0.242 AT Availability likely +9%
Derma-Smoothe/FS .11 mg/mL 68791-0101-04 Royal 1 bottle $0.243 AT Availability likely +9%
Fluocinolone Acetonide Oil .11 mg/mL 50090-6780-00 A-S 118.28 ml — AT FDA listed —
Fluocinolone acetonide .01 mg/100mL 50090-7958-00 A-S 1 bottle — AT FDA listed —
fluocinolone acetonide .01 mg/100mL 63629-8655-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone acetonide .01 mg/100mL 63629-8656-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 71335-2883-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 71335-2884-01 Bryant 1 bottle — AT FDA listed —
Fluocinolone acetonide .01 mg/100mL 72162-1412-02 Bryant 1 bottle — AT FDA listed —
fluocinolone acetonide .01 mg/100mL 72162-1434-02 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 72162-2319-02 Bryant 1 bottle — AT FDA listed —
Fluocinolone Acetonide .11 mg/mL 72162-2321-02 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 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.

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.

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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA201759 (ANDA)
Labeler code65162
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio490 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.

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65162-0700-76 · Amneal 65162-0705-88 · Amneal →
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.