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Desoximetasone .5 mg/g Ointment — NDC 83148-0021-60 package photo

Desoximetasone .5 mg/g Ointment

by The J. Molner Company LLC · 1 TUBE in 1 CARTON (83148-021-60) / 60 g in 1 TUBE
NDC 83148-0021-60
🏷️ FDA NDC (as labeled) 83148-021-60 billing pads the product segment with a zero
This package
Contains60 g in 1 tube Cost per g$0.8932 NADAC Per package$53.59 / 60 g Pack sizes2 compare ↓
Also priced by: Part D plans $2.11/unit — full pricing hub ↓
Also comes in: 100 g 83148-0021-99
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 83148-021-60
Product NDC 83148-021
11-digit billing NDC 83148002160
NCPDP billing unit GM — per gram (weight)
RxCUI 141850
UNII 4E07GXB7AU
Application # ANDA209973
SPL Set ID 2bbb5200-8355-ba86-e063-6394a90a23b6
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 2025-02-01
Route TOPICAL
Dosage form OINTMENT
Substance DESOXIMETASONE
GPI-14 90550040004203
GCN Seq No 041987
GCN 11403
HICL code 003309
Ingredient (HICL) Desoximetasone
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name DESOXIMETASONE 0.05% OINTMENT
FDB brand name Desoximetasone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 83148-021-60 — 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 → 83148-0021-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerThe J. Molner Company LLC
Application holderTHE J MOLNER CO OU
FDA applicationANDA209973 (ANDA)
Labeler code83148
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio5 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DESOXIMETASONE 0.05% OINTMENT Ingredient Desoximetasone
📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Desoximetasone is a prescription steroid cream, ointment, gel, or spray applied to the skin to calm inflammation and itching. The creams, gels, and ointments are used for a range o...
  • What exactly is desoximetasone used for?
  • Apply a thin film to the affected area twice a day and rub it in gently. Use it only on the skin areas your doctor pointed out — and only for external use, never near your eyes, in...
  • For the topical spray, the label recommends stopping treatment once your skin improves and not using it for longer than 4 weeks. For the creams, gel, and ointments, follow your doc...
📖 Read our full Desoximetasone guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Desoximetasone — tap one for details:

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.

2 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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.893 $53.59 / 60 g
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $2.11 $126.75 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $1.874 $0.717
▼ Down 52% over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Desoximetasone .5 mg/gthis 83148-0021-60 The 1 tube $0.893 AB Availability likely
Desoximetasone .5 mg/g 51672-1261-01 Sun 1 tube $3.751 AB Availability likely +320%
Desoximetasone .5 mg/g 51672-1352-01 Sun 1 tube AB FDA listed
Topicort .5 mg/g 51672-5263-01 Sun 1 tube AB FDA listed
Desoximetasone .5 mg/g 68180-0948-01 Lupin 1 tube AB FDA listed
Desoximetasone .5 mg/g 72162-2629-01 Bryant 1 tube AB FDA listed
Desoximetasone .5 mg/g 71656-0086-15 Saptalis 15 tubes AB Discontinued
Desoximetasone .5 mg/g 51672-1271-01 Sun 1 tube AB FDA listed
Desoximetasone .5 mg/g 68180-0949-01 Lupin 1 tube AB 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

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

Medicare Part D (outpatient prescription) spending for Desoximetasone — the program that covers self-administered drugs. 6 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 Desoximetasone. 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
$632.4K
Claims incl. refills
9K
Beneficiaries
7.4K
Spend / beneficiary
$85.57
Spend / claim
$69.95
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Desoximetasone — the ingredient across all brands.

Top reported reactions

Pain9,038
Fatigue8,954
Rheumatoid Arthritis8,336
Alopecia8,331
Systemic Lupus Erythematosus8,263
Pemphigus8,003
Abdominal Discomfort7,923

Age at onset

Neonate89
Infant7
Child26
Adolescent38
Adult3,423
Elderly589

Reporter sex

18,942 reports
Male · 11%
Female · 89%
Unknown · 0%

Serious outcomes

Hospitalization7,098
Disabling7,042
Life-threatening5,390
Death5,061
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,177 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
83148-0021-60 You're viewing this 1 TUBE in 1 CARTON (83148-021-60) / 60 g in 1 TUBE $0.8932 / g $53.59 2025-02-01 Active
83148-0021-99 1 TUBE in 1 CARTON (83148-021-99) / 100 g in 1 TUBE 2025-05-01 Active

Pack size FAQ

What quantity is in NDC 83148-0021-60?
NDC 83148-0021-60 is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of Desoximetasone .5 mg/g Ointment?
Bill NDC 83148-0021-60 — the 11-digit billing format is 83148002160. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 21 words

INDICATIONS AND USAGE Desoximetasone Ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 22 words

DOSAGE AND ADMINISTRATION Apply a thin film of Desoximetasone Ointment USP, 0.05% to the affected skin areas twice daily. Rub in gently.

Contraindications 23 words

CONTRAINDICATIONS Desoximetasone Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

⚠️ Warnings 7 words

WARNINGS Keep out of reach of children.

🤒 Adverse Reactions 107 words

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In controlled clinical studies the incidence of adverse reactions was low (0.2%) for Desoximetasone Ointment USP, 0.05% and included mild burning sensation at the site of application.

To report SUSPECTED ADVERSE REACTIONS , contact The J. Molner Company LLC at 1-800-552-8750 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 135 words

Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 15 to 150 times the human dose of Desoximetasone Ointment USP, 0.05%.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Desoximetasone Ointment USP, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

🧒 Pediatric Use 118 words

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension 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 absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

🆘 Overdosage 17 words

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile. Pharmacokinetic studies in men with desoximetasone ointment 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 μg/mL) in 1 subject and 0.004 and 0.006 μg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces.

Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.

📦 How Supplied / Storage and Handling 46 words

HOW SUPPLIED Desoximetasone Ointment USP, 0.05% is supplied in: 60 gram tubes (NDC 83148-021-60) and 100 gram tubes (NDC 83148-021-99). Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

📦 Storage and Handling 26 words

Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

📋 Description 86 words

DESCRIPTION Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum.

The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.

The structural formula is: Chemical Structure

💬 Information for Patients 134 words

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

Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions, especially under occlusive dressings.

Other corticosteroid-containing products should not be used with Desoximetasone Ointment USP, 0.05% without first consulting with the physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.