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fluocinolone acetonide .01 mg/100mL Oil, 1 bottle — NDC 45802-887-26 (Billing 45802-0887-26)

by Padagis Israel Pharmaceuticals Ltd · 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE

This is a package of 1 bottle of fluocinolone acetonide .01 mg/100mL Oil from Padagis Israel Pharmaceuticals Ltd, marketed since Jun 2017 and currently FDA-listed; retail pharmacies pay about $0.1755 per mL (NADAC). It is this product's only package size.

NDC 45802-0887-26
🏷️ FDA NDC (as labeled) 45802-887-26 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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) 45802-887-26
Product NDC 45802-887
11-digit billing NDC 45802088726
NCPDP billing unit ML — per mL (volume)
UNII 0CD5FD6S2M
Application # ANDA202847
SPL Set ID ba20d901-f800-4edd-aac6-6c77cbfe1064
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 2017-06-14
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 45802-887-26 — 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 → 45802-0887-26. 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 $0.2300 $27.20 / 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
45802-0887-26 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE 2017-06-14 — 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/100mLthis 45802-0887-26 Padagis 1 bottle $0.175 AT Availability likely —
Fluocinolone Acetonide .11 mg/118.28mL 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

🏛️
2017
On the market since
Jun 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 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.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA202847 (ANDA)
Labeler code45802
First marketedJun 2017
Product typeHuman Prescription Drug
Portfolio175 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 74 words ▾

1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil is indicated for the topical treatment of: • atopic dermatitis in adults • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older Fluocinolone acetonide topical oil is a corticosteroid indicated for the topical treatment of: • atopic dermatitis in adults ( 1 ) • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Fluocinolone acetonide topical oil is not for oral, ophthalmic, or intravaginal use. ( 2.1 ) • Do not use on face or intertriginous areas. ( 2.1 ) • Adult patients: Apply to affected areas 3 times daily. ( 2.2 ) • Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.3 )

2.1Important Administration Instructions Fluocinolone acetonide topical oil is for topical use only. Not for oral, ophthalmic, or intravaginal use. Apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas.

Discontinue use when control of disease is achieved within 2 weeks or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use on the face, axillae, or groin unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions ( 6 ) and Use in Specific Populations ( 8.4 )] .

Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use [see Warnings and Precautions ( 5.1 )] .

2.2Recommended Dosage in Adults Apply fluocinolone acetonide topical oil as a thin film to the affected areas three times daily .

2.3Recommended Dosage in Pediatric Patients 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 52 words ▾

3 DOSAGE FORMS AND STRENGTHS Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces. Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is a topical oil containing 0.01% fluocinolone acetonide 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 • Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) o Pediatric patients may be more susceptible to systemic toxicity from equivalent doses. ( 5.1 , 8.4 ) o Systemic absorption may require evaluation for HPA axis suppression.

Potent corticosteroids use on large areas, prolonged use, occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption. Modify use should HPA axis suppression develop. ( 5.1 ) • Local Adverse Reactions: 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 , 6.1 ) • Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract. Avoid contact of fluocinolone acetonide topical oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

( 5.3 )

5.1Endocrine System Adverse Reactions 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 result from systemic absorption of topical corticosteroids. HPA axis suppression and Cushing’s syndrome have been reported in pediatric patients receiving topical corticosteroids.

Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Pediatric patients 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 )]. Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. 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, reduce the frequency of application or discontinue fluocinolone acetonide topical oil, or substitute with a less potent corticosteroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

5.2Local Adverse Reactions Local adverse reactions may occur with use of topical corticosteroids, including fluocinolone acetonide topical oil, 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 )].

5.3Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of fluocinolone acetonide topical oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.4Allergic Contact Dermatitis Use of topical corticosteroids can… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).

( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies Experience 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. An open-label trial was conducted in 58 pediatric subjects 2 years to 12 years of age with moderate to severe atopic dermatitis to evaluate the safety of fluocinolone acetonide topical oil when applied to the face twice daily for 4 weeks.

Adverse reactions reported by ≥2% of pediatric subjects treated with fluocinolone acetonide topical oil are shown in Table 1. Table 1: Adverse Reactions in ≥2% of Pediatric Subjects 2 Years to 12 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with Fluocinolone Acetonide Topical Oil (Body Oil), N=58 Adverse Reaction (AR)* n (%) Day 14 Day 28** Day 56*** 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) *The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reports of an adverse reaction. **End of Treatment ***Four Weeks Post Treatment An open-label safety trial was conducted in 29 pediatric subjects 3 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.

The trial included 7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area (BSA). Eleven (11) subjects had baseline BSA involvement of 50% to 75% and 7 subjects had BSA involvement of greater than 75% [see Use in Specific Populations ( 8.4 )].

The most common adverse reactions reported in the study (≥2%) are shown in Table 2. Table 2: Adverse Reactions in ≥ 2% of Pediatric Subjects 3 Months to 2 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with Fluocinolone Acetonide Topical Oil (Body Oil), N=30* Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3) *Includes one subject who withdrew at Week 2

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Endocrine Disorders: HPA axis suppression and Cushing’s syndrome [see Use in Specific Populations ( 8.4 )] • Eye Disorders: glaucoma and cataracts [se… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use fluocinolone acetonide topical oil on the smallest area of skin and for the shortest duration possible.

Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of fluocinolone acetonide in breast milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use fluocinolone acetonide topical oil on the smallest area of skin and for the shortest duration possible while breastfeeding.

Advise breastfeeding women not to apply fluocinolone acetonide topical oil directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluocinolone acetonide topical oil and any potential adverse effects on the breastfed infant from fluocinolone acetonide topical oil or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of fluocinolone acetonide topical oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks. Safety and effectiveness of fluocinolone acetonide topical oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients 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, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions ( 5.1 )].

Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of fluocinolone acetonide topical oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric 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 trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, fluocinolone acetonide topical oil and histamine/saline controls. Subjects were also treated with fluo… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 166 words ▾

8.1Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use fluocinolone acetonide topical oil on the smallest area of skin and for the shortest duration possible.

Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of fluocinolone acetonide topical oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks. Safety and effectiveness of fluocinolone acetonide topical oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients 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, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions ( 5.1 )].

Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of fluocinolone acetonide topical oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric 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 trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, 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. Evaluation in Pediatric Patients 2 to 6 years old Use of fluocinolone acetonide topical oil in pediatric patients 2 to 6 years old is supported by open-label safety trials conducted in 33 pediatric subjects (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects.

Subjects were treated with fluocinolone acetonide topical oil twice daily for 4 weeks. 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) [see Clinical Pharmacology ( 12.2 )] .

Evaluation in Pediatric Patients 3 months to 2 years old Use of fluocinolone acetonide topical oil in pediatric patients 3 months to 2 years old is supported by an open-label safety trial conducted in 29 pediatric subjects (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil twice daily for 4 weeks [see Adverse Reactions ( 6.1 )] . 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) [see Clinical Pharmacology ( 12.2 )].

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.

12.2Pharmacodynamics Vasoconstrictor Assay Fluocinolone acetonide topical oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression was evaluated in 29 pediatric subjects 3 months to 2 years old (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) and 33 pediatric subjects 2 years to 12 years old (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe atopic dermatitis.

Subjects were treated with fluocinolone acetonide topical oil twice daily for 4 weeks. 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. In subjects 3 months to 2 years old, all subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).

In subjects 2 to 12 years old, 4 out of 18 subjects 2 to 5 years old 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) at the end of treatment [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] .

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.

🧬 Mechanism of Action 28 words ▾

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.

📦 How Supplied / Storage and Handling 44 words ▾

16 HOW SUPPLIED / STORAGE AND HANDLING Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) (NDC 45802- 887 -26) is supplied in bottles containing 4 fluid ounces. Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

📋 Description 157 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. 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% (Body 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.

The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes. Structural Formula

💬 Information for Patients ~1 min read ▾

Administration Instructions Advise patients that fluocinolone acetonide topical oil is for topical use only [see Dosage and Administration ( 2.1 )] . Advise patients to not to apply fluocinolone acetonide topical oil under occlusion unless directed by their healthcare provider. Instruct patients not to apply fluocinolone acetonide topical oil to the diaper area as diapers or plastic pants may constitute occlusive use [see Dosage and Administration ( 2.1 )] .

Advise patients to avoid use of fluocinolone acetonide topical oil on the face, axillae, or groin unless directed by their healthcare provider [see Dosage and Administration ( 2.1 )] . Advise patients to discontinue therapy when control of disease is achieved. Instruct patients to contact their healthcare provider if no improvement is seen within 2 weeks [see Dosage and Administration ( 2.1 )] .

Endocrine System Adverse Reactions Instruct patients not to use other corticosteroid-containing products while using fluocinolone acetonide topical oil without first consulting their healthcare provider [see Warnings and Precautions ( 5.1 )] . Ophthalmic Adverse Reactions Advise patients to avoid contact with the eyes and in case of contact, wash eyes liberally with water. Instruct patients to tell their healthcare provider if they develop any visual symptoms [see Warnings and Precautions ( 5.3 )] .

Pregnancy and Lactation Advise patients to use fluocinolone acetonide topical oil on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise patients that are breastfeeding not to apply fluocinolone acetonide topical oil directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( 8.1 and 8.2 )]. Manufactured by Padagis ® , Yeruham, Israel 8R726 RC F8

🧬 Pharmacokinetics 109 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.

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Vasoconstrictor Assay Fluocinolone acetonide topical oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression was evaluated in 29 pediatric subjects 3 months to 2 years old (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) and 33 pediatric subjects 2 years to 12 years old (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe atopic dermatitis.

Subjects were treated with fluocinolone acetonide topical oil twice daily for 4 weeks. 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. In subjects 3 months to 2 years old, all subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).

In subjects 2 to 12 years old, 4 out of 18 subjects 2 to 5 years old 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) at the end of treatment [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] .

🧪 Nonclinical Toxicology 67 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, mutagenesis, impairment of fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with fluocinolone acetonide topical oil. However, some corticosteroids are 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 64 words ▾

13.1Carcinogenesis, mutagenesis, impairment of fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with fluocinolone acetonide topical oil. However, some corticosteroids are 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).

📄 Package Label / Principal Display Panel 43 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-887-26 Rx Only Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE SHAKE WELL BEFORE USE NET CONTENTS 118.28 mL (4 FL OZ) Fluocinolone Acetonide Topical Oil bottle label

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
2.4K
Units reimbursed last 4 qtrs
291.9K
Gross reimbursed last 4 qtrs
$67.1K
Avg / prescription
$27.46
Avg / unit
$0.2300
Latest quarter Q1 2026
523Rx
Medicaid pays / mL
$0.2300
gross reimbursed
vs
NADAC / mL
$0.1755
acquisition cost
=
Spread
+$0.0545
+31% 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 ⓘ
45% FFS 55% MCO
Fee-for-service · 1,107 Rx Managed care · 1,338 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 1,538 units · 196 per 100k residents ND Minnesota: 11,473 units · 200 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 44,473 units · 227 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 6,387 units · 50.9 per 100k residents IL Indiana: no data reported IN Ohio: 36,903 units · 313 per 100k residents OH Pennsylvania: 6,031 units · 46.5 per 100k residents PA New Jersey: 1,301 units · 14.0 per 100k residents NJ Massachusetts: 1,301 units · 18.6 per 100k residents MA California: 84,147 units · 216 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: no data reported WV Virginia: 1,656 units · 19.0 per 100k residents VA Maryland: 9,464 units · 153 per 100k residents MD Connecticut: no data reported 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: no data reported TN North Carolina: 15,731 units · 145 per 100k residents NC South Carolina: 21,169 units · 394 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 2,838 units · 55.6 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 47,511 units · 156 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
14.0394
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 394 /100k
2 Ohio 313 /100k
3 New York 227 /100k
4 California 216 /100k
5 Minnesota 200 /100k
6 North Dakota 196 /100k
7 Texas 156 /100k
8 Maryland 153 /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.
← 45802-0880-14 · Padagis 45802-0888-30 · Padagis →
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.