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Fluocinolone Acetonide .11 mg/118.28mL Oil, 1 bottle — NDC 51672-1356-8 (Billing 51672-1356-08)

by Sun Pharmaceutical Industries, Inc. · 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 Sun Pharmaceutical Industries, Inc., marketed since May 2016 and currently FDA-listed; retail pharmacies pay about $0.1755 per mL (NADAC). It is this product's only package size.

NDC 51672-1356-08
🏷️ FDA NDC (as labeled) 51672-1356-8 billing pads the package 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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-1356-8
Product NDC 51672-1356
11-digit billing NDC 51672135608
NCPDP billing unit ML — per mL (volume)
UNII 0CD5FD6S2M
Application # ANDA202368
SPL Set ID 22e9909a-47d2-4331-9b92-e7c4c2acf739
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 2016-05-19
Route TOPICAL
Dosage form OIL
Substance FLUOCINOLONE ACETONIDE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90550055101712
GPI class Fluocinolone Acetonide Body
GCN Seq No 007507
GCN 85080
HICL code 002896
Ingredient (HICL) Fluocinolone Acetonide
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 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name FLUOCINOLONE 0.01% BODY OIL
FDB brand name Fluocinolone Acetonide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007507
  • GCN: 85080
  • GPI-14 (Medi-Span): 90550055101712
  • HICL (First Databank): 002896
  • AHFS class code: 52:08.08.00
Why two NDCs? The FDA registers this code as 51672-1356-8 — 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 → 51672-1356-08. 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% BODY OIL Ingredient Fluocinolone Acetonide
📗 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 $0.176 $20.76 / 118.28 ml
Medicaid paysCMS SDUD · 12 mo $0.2516 $29.76 / 118.28 ml
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.268 $0.169
▼ Down 32% 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
51672-1356-08 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE 2016-05-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluocinolone acetonide .01 mg/100mL 45802-0485-26 Padagis 1 bottle $0.171 AT Availability likely save 2%
Fluocinolone Acetonide .11 mg/118.28mL 51672-1357-08 Sun 1 bottle $0.171 AT Availability likely save 2%
FLUOCINOLONE ACETONIDE Oil .11 mg/mL 64980-0330-04 RISING 118.28 ml $0.171 AT Availability likely save 2%
Fluocinolone Acetonide .11 mg/mL 70752-0158-06 Quagen 1 bottle $0.171 AT Availability likely save 2%
fluocinolone acetonide .01 mg/100mL 45802-0887-26 Padagis 1 bottle $0.175 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mLthis 51672-1356-08 Sun 1 bottle $0.175 AT Availability likely —
Fluocinolone Acetonide Oil .11 mg/mL 64980-0331-04 Rising 118.28 ml $0.175 AT Availability likely —
Fluocinolone Acetonide .11 mg/mL 70752-0156-06 Quagen 1 bottle $0.175 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 65162-0703-86 Amneal 1 bottle $0.222 — Discontinued +26%
Fluocinolone Acetonide .11 mg/mL 68462-0590-89 Glenmark 1 bottle $0.222 — FDA listed +26%
Derma-Smoothe/Fs .11 mg/mL 68791-0102-04 Royal 1 bottle $0.242 AT Availability likely +38%
Derma-Smoothe/FS .11 mg/mL 68791-0101-04 Royal 1 bottle $0.243 AT Availability likely +38%
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

🏛️
2016
On the market since
May 2016
📍
2026
Currently FDA-listed
10 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA202368 (ANDA)
Labeler code51672
First marketedMay 2016
Product typeHuman Prescription Drug
Portfolio890 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) Do not use in the diaper area.

( 1.3 ) Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 )

1.1Adult Patients with Atopic Dermatitis Fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients.

1.2Pediatric Patients with Atopic Dermatitis Fluocinolone acetonide topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

1.3Limitations of Use Apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Fluocinolone acetonide topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [ see Adverse Reactions (6) and Use in Specific Populations (8.4) ].

⏱️ Dosage and Administration 129 words ▾

2 DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil is not for oral, ophthalmic, or intravaginal use. The dosing of fluocinolone acetonide topical oil is different for adult and pediatric patients. Fluocinolone acetonide topical oil is not for oral, ophthalmic, or intravaginal use.

( 2 ) Adult patients: Apply to affected areas 3 times daily. ( 2.1 ) Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.2 )

2.1Adult Patients with Atopic Dermatitis Apply fluocinolone acetonide topical oil as a thin film to the affected areas three times daily .

2.2Pediatric Patients with Atopic Dermatitis Moisten skin and apply fluocinolone acetonide topical oil as a thin film to the affected areas twice daily for up to four weeks .

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Fluocinolone acetonide topical oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. Fluocinolone acetonide topical oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. ( 5.1 ) Modify use should HPA axis suppression develop.

( 5.1 ) Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. ( 5.1 ) Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids ( 5.2 , 5.3 , 6.1 ) Children may be more susceptible to systemic toxicity from equivalent doses. ( 5.1 , 8.4 )

5.1Hypothalamic-Pituitary-Adrenal Axis Suppression Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroids. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. [ See Use in Specific Populations (8.4) ]

5.2Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. [ See Adverse Reactions (6.1) ]

5.3Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.4Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists unchanged, fluocinolone acetonide topical oil should be discontinued until the infection has been adequately treated.

5.5Use in Peanut-Sensitive Individuals Physicians should use caution in prescribing fluocinolone acetonide topical oil for peanut-sensitive individuals. [ See Description (11) ] Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, fluocinolone acetonide topical oil should be discontinued immediately and appropriate therapy instituted.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil when applied to the face twice daily for 4 weeks. The following adverse reactions were reported: Incidence of Adverse Reactions (%), N=58 Adverse Reaction (AR) The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction. # of subjects (%) Day 14 Day 28 End of Treatment Day 56 Four Weeks Post Treatment Any AE 15 (26) 6 (10) 7 (12) 7 (12) Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4) Erythema 3 (5) 3 (5) Itching 3 (5) 3 (5) Irritation 3 (5) 3 (5) Burning 3 (5) 3 (5) Hypopigmentation 2 (4) 2 (4) Shiny Skin 1 (2) 1 (2) Secondary atopic dermatitis 1 (2) 1 (2) Papules and pustules 1 (2) 1 (2) Keratosis pilaris 1 (2) 1 (2) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2)

6.2Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil twice daily for 4 weeks. The following adverse reactions were reported in the study [ See Use in Specific Populations (8.4) ]: Adverse Reactions (%), N=30 Includes one subject who withdrew at Week 2 Adverse Reaction # of subjects (%) Diarrhea 1 (3) Vomiting 1 (3) Pyrexia 3 (10) Abscess 1 (3) Molluscum 1 (3) Nasopharyngitis 2 (7) URI 1 (3) Otitis media 1 (3) Cough 6 (20) Rhinorrhea 4 (13) Atopic dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Hypopigmentation 2 (7) Rash 1 (3)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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 topical oil.

Therefore, fluocinolone acetonide topical oil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide topical oil is administered to a nursing woman.

8.4Pediatric Use 8.4.1 Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [ see Warnings and Precautions (5.1) ] 8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls).

The study evaluated the subjects' responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil and histamine/saline controls. Subjects were also treated with fluocinolone acetonide topical oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil and the refined peanut oil.

One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil. The bulk peanut oil NF, used in fluocinolone acetonide topical oil is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [ See Description (11) ] 8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis.

Subjects were treated with fluocinolone acetonide topical oil twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.

At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL). 8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 74 words ▾

8.1Pregnancy 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 topical oil.

Therefore, fluocinolone acetonide topical oil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use 8.4.1 Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [ see Warnings and Precautions (5.1) ] 8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls).

The study evaluated the subjects' responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil and histamine/saline controls. Subjects were also treated with fluocinolone acetonide topical oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil and the refined peanut oil.

One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil. The bulk peanut oil NF, used in fluocinolone acetonide topical oil is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [ See Description (11) ] 8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis.

Subjects were treated with fluocinolone acetonide topical oil twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.

At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL). 8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil twice daily for 4 weeks.

All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.

All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).

🆘 Overdosage 34 words ▾

10 OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [ See Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].

🧬 Clinical Pharmacology 220 words ▾

12 CINICAL PHARMACOLOGY

12.1Mechanism of Action 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 A2 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 A2.

12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption.

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Fluocinolone acetonide topical oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

🧬 Mechanism of Action 86 words ▾

12.1Mechanism of Action 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 A2 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 A2.

📦 How Supplied / Storage and Handling 44 words ▾

16 HOW SUPPLIED / STORAGE AND HANDLING Fluocinolone acetonide topical oil is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC 51672-1356-8). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

📦 Storage and Handling 17 words ▾

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

📋 Description 178 words ▾

11 DESCRIPTION Fluocinolone acetonide topical oil, 0.01% (Body 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% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 .

It has the following structural formula: Fluocinolone acetonide in fluocinolone acetonide topical oil 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 contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil.

Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide 0.01% Topical Oil for peanut-sensitive individuals. Chemical Structure

💬 Information for Patients 167 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Instructions Fluocinolone acetonide topical oil should be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

In case of contact, wash eyes liberally with water. Fluocinolone acetonide topical oil should not be used for any disorder other than that for which it was prescribed. Patients should report any worsening of their skin condition to their physician promptly.

Fluocinolone acetonide topical oil should not be applied under occlusion unless directed by the physician. Fluocinolone acetonide topical oil should not be applied to the diaper area as diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil should not be used on the face, axillae, or groin unless directed by the physician.

As with other corticosteroids, therapy should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Do not use other corticosteroid-containing products while using fluocinolone acetonide topical oil without first consulting your physician.

🍼 Nursing Mothers 69 words ▾

8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide topical oil is administered to a nursing woman.

🧬 Pharmacokinetics 131 words ▾

12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption.

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Fluocinolone acetonide topical oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

🧪 Nonclinical Toxicology 100 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, mutagenesis, impairment of fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide topical oil. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide topical oil. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test, and the in vitro mouse lymphoma gene mutation assay).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 97 words ▾

13.1Carcinogenesis, mutagenesis, impairment of fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide topical oil. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide topical oil. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test, and the in vitro mouse lymphoma gene mutation assay).

📖 Instructions for Use 163 words ▾

17.1Instructions Fluocinolone acetonide topical oil should be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

In case of contact, wash eyes liberally with water. Fluocinolone acetonide topical oil should not be used for any disorder other than that for which it was prescribed. Patients should report any worsening of their skin condition to their physician promptly.

Fluocinolone acetonide topical oil should not be applied under occlusion unless directed by the physician. Fluocinolone acetonide topical oil should not be applied to the diaper area as diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil should not be used on the face, axillae, or groin unless directed by the physician.

As with other corticosteroids, therapy should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Do not use other corticosteroid-containing products while using fluocinolone acetonide topical oil without first consulting your physician.

📄 Recent Major Changes 12 words ▾

Indication and Usage, Pediatric Patients with Atopic Dermatitis ( 1.2 ) 11/2007

📄 Package Label / Principal Display Panel 61 words ▾

PRINCIPAL DISPLAY PANEL - 118.28 mL Bottle Carton 4 fl. oz. Net Contents 118.28 mL NDC 51672-1356-8 Fluocinolone Acetonide Topical Oil 0.01% (BODY OIL) For Topical Use Only Not for Oral, Ophthalmic, or Intravaginal Use SHAKE WELL BEFORE USE Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 118.28 mL Bottle 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
31.8K
Units reimbursed last 4 qtrs
3.8M
Gross reimbursed last 4 qtrs
$961.6K
Avg / prescription
$30.28
Avg / unit
$0.2516
Latest quarter Q1 2026
7.4KRx
Medicaid pays / mL
$0.2516
gross reimbursed
vs
NADAC / mL
$0.1755
acquisition cost
=
Spread
+$0.0761
+43% 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 ⓘ
38% FFS 62% MCO
Fee-for-service · 12,035 Rx Managed care · 19,725 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 10,054 units · 129 per 100k residents WA Idaho: 2,839 units · 145 per 100k residents ID Montana: no data reported MT North Dakota: 1,419 units · 181 per 100k residents ND Minnesota: 57,397 units · 1,000 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,140 units · 41.2 per 100k residents MI New York: 50,090 units · 256 per 100k residents NY Vermont: no data reported VT New Hampshire: 16,323 units · 1,164 per 100k residents NH Oregon: no data reported OR Nevada: 21,527 units · 674 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 9,936 units · 310 per 100k residents IA Illinois: 65,290 units · 520 per 100k residents IL Indiana: 28,151 units · 410 per 100k residents IN Ohio: 533,916 units · 4,530 per 100k residents OH Pennsylvania: 91,792 units · 708 per 100k residents PA New Jersey: 13,129 units · 141 per 100k residents NJ Massachusetts: 166,182 units · 2,374 per 100k residents MA California: 1,194,429 units · 3,065 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: 14,075 units · 795 per 100k residents WV Virginia: 65,765 units · 755 per 100k residents VA Maryland: 131,291 units · 2,124 per 100k residents MD Connecticut: 6,979 units · 193 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 25,194 units · 354 per 100k residents TN North Carolina: 299,012 units · 2,760 per 100k residents NC South Carolina: 501,387 units · 9,332 per 100k residents SC Delaware: 1,656 units · 161 per 100k residents DE Oklahoma: no data reported OK Louisiana: 20,580 units · 450 per 100k residents LA Mississippi: 4,613 units · 157 per 100k residents MS Alabama: 82,626 units · 1,618 per 100k residents AL Georgia: 99,002 units · 898 per 100k residents GA D.C.: 4,733 units · 697 per 100k residents DC Hawaii: no data reported HI Texas: 290,500 units · 952 per 100k residents TX Florida: 7,806 units · 34.5 per 100k residents FL
Units reimbursed · per 100k residents
34.59,332
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 South Carolina 9,332 /100k
2 Ohio 4,530 /100k
3 California 3,065 /100k
4 North Carolina 2,760 /100k
5 Massachusetts 2,374 /100k
6 Maryland 2,124 /100k
7 Alabama 1,618 /100k
8 New Hampshire 1,164 /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 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.
← 51672-1353-02 · Sun 51672-1357-08 · Sun →
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.