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Fluocinolone Acetonide .11 mg/mL Oil, 1 bottle — NDC 71335-2883-01 package photo

Fluocinolone Acetonide .11 mg/mL Oil, 1 bottle

by Bryant Ranch Prepack · 1 BOTTLE in 1 CARTON (71335-2883-1) / 118.28 mL in 1 BOTTLE
NDC 71335-2883-01
🏷️ FDA NDC (as labeled) 71335-2883-1 billing pads the package 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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-2883-1
Product NDC 71335-2883
11-digit billing NDC 71335288301
NCPDP billing unit ML — per mL (volume)
RxCUI 1191307
UNII 0CD5FD6S2M
Application # ANDA212761
SPL Set ID 1539d6ac-b527-4ff0-afe4-083ceac655f3
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 2021-04-02
Route TOPICAL
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE
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
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 71335-2883-1 — a 5-4-1 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 package segment → 71335-2883-01. 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

LabelerBryant Ranch Prepack
Application holderQUAGEN PHARMACEUTICALS LLC
FDA applicationANDA212761 (ANDA)
Labeler code71335
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio4,434 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 0.01% SCALP OIL Ingredient Fluocinolone/Shower Cap
📖 What it is MedlinePlus · NLM

Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 .01 mg/100mL 45802-0485-26 Padagis 1 bottle $0.168 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 51672-1357-08 Sun 1 bottle $0.168 AT Availability likely —
FLUOCINOLONE ACETONIDE Oil .11 mg/mL 64980-0330-04 RISING 118.28 ml $0.168 AT Availability likely —
Fluocinolone Acetonide .11 mg/mL 70752-0158-06 Quagen 1 bottle $0.168 AT Availability likely —
fluocinolone acetonide .01 mg/100mL 45802-0887-26 Padagis 1 bottle $0.178 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 51672-1356-08 Sun 1 bottle $0.178 AT Availability likely —
Fluocinolone Acetonide Oil .11 mg/mL 64980-0331-04 Rising 118.28 ml $0.178 AT Availability likely —
Fluocinolone Acetonide .11 mg/mL 70752-0156-06 Quagen 1 bottle $0.178 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 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 —
Derma-Smoothe/FS .11 mg/mL 68791-0101-04 Royal 1 bottle $0.242 AT Availability likely —
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/mLthis 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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
71335-2883-01 You're viewing this 1 BOTTLE in 1 CARTON (71335-2883-1) / 118.28 mL in 1 BOTTLE 2025-11-11 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 FDA registers it as 71335-2883-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-2883-01, written without dashes as 71335288301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-2883-01, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2883) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 29 words ▾

INDICATION AND USAGE Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (scalp oil).

⏱️ Dosage and Administration 72 words ▾

DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil, 0.01% for scalp psoriasis in adults (scalp oil): For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of fluocinolone acetonide topical oil, 0.01% on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.

⛔ Contraindications 34 words ▾

CONTRAINDICATIONS Fluocinolone acetonide topical oil, 0.01% 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 section).

🤒 Adverse Reactions ~1 min read ▾

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%. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events ). Incidence of Adverse Events (%) N=58 Adverse Event (AE) * # of patients (%) Day 14 Day 28 † D ay 56 ‡ * The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. † End of Treat ment ‡ Four Weeks Post Treatment Any AE 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) Telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) Erythema 3 (5.2) 3 (5.2) Itching 3 (5.2) 3 (5.2) Irritation 3 (5.2) 3 (5.2) Burning 3 (5.2) 3 (5.2) Hypopigmentation 2 (3.5) 2 (3.5) Shiny skin 1 (1.7) 1 (1.7) Secondary atopic dermatitis 1 (1.7) 1 (1.7) Papules and pustules 1 (1.7) 1 (1.7) Keratosis pilaris 1 (1.7) 1 (1.7) Folliculitis 1 (1.7) 1 (1.7) Facial herpes simplex 1 (1.7) 1 (1.7) Acneiform eruption 1 (1.7) 1 (1.7) Ear infection 1 (1.7) 1 (1.7) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 21 words ▾

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

🧬 Clinical Pharmacology 160 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 topical oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 73 words ▾

HOW SUPPLIED Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied in bottles containing 4 fluid ounces. It is labeled as fluocinolone acetonide topical oil, 0.01% (scalp oil) (NDC # 71335-2883-1). Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied with 2 shower caps.

Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 191 words ▾

DESCRIPTION Fluocinolone acetonide topical oil, 0.01% (scalp oil) contains fluocinolone acetonide {(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 for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis.

Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-2882-01 · Bryant 71335-2884-01 · Bryant →
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.