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Clobetasol Propionate .5 mg/g Ointment — NDC 00713-0656-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clobetasol Propionate .5 mg/g Ointment — NDC 0713-0656-15 (Billing 00713-0656-15)

by Cosette Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Clobetasol Propionate .5 mg/g Ointment from Cosette Pharmaceuticals, Inc., marketed since Jan 2016 and currently FDA-listed; retail pharmacies pay about $0.1383 per g (NADAC).

NDC 00713-0656-15
🏷️ FDA NDC (as labeled) 0713-0656-15 billing pads the labeler segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.1383 NADAC Per package$2.07 / 15 g Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.5087/unit · Part D plans $0.2669/unit — full pricing hub ↓
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 →
⚠️
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 3, 2026 — Failed content uniformity specifications. (Lupin Pharmaceuticals Inc.) · FDA recall D-0789-2026
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) 0713-0656-15
Product NDC 0713-0656
11-digit billing NDC 00713065615
NCPDP billing unit GM — per gram (weight)
RxCUI 861448
UNII 779619577M
UPC 0307130656313
Application # ANDA074089
SPL Set ID 807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f
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 2016-01-04
Route TOPICAL
Dosage form OINTMENT
Substance CLOBETASOL PROPIONATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90550025104205
GPI class Clobetasol Propionate
GCN Seq No 007635
GCN 32130
HICL code 003327
Ingredient (HICL) Clobetasol Propionate
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 CLOBETASOL 0.05% OINTMENT
FDB brand name Clobetasol Propionate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007635
  • GCN: 32130
  • GPI-14 (Medi-Span): 90550025104205
  • HICL (First Databank): 003327
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 861448
Why two NDCs? The FDA registers this code as 0713-0656-15 — a 4-4-2 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 labeler segment → 00713-0656-15. 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, very potent (group IV), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLOBETASOL 0.05% OINTMENT Ingredient Clobetasol Propionate
📖 What it is MedlinePlus · NLM

Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and 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). Clobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It calms inflamed, itchy skin and scalp conditions, including plaque psoriasis. The exact use depends on your product, such as shampoo for scalp psoriasis or spray for plaque psori...
  • Usually only a short time, often 2 weeks and up to 4 weeks for some products. Stop when your skin is under control. If you see no improvement in 2 weeks, check back with your presc...
  • Generally no. Most clobetasol skin products should not be used on the face, armpits or groin. Keep it out of your eyes and mouth, and follow your product's directions.
  • Mild burning, stinging, itching or dryness where you apply it. Call your doctor if your skin thins, breaks out, looks infected or gets worse. Also call for signs of steroid effects...
📖 Read our full Clobetasol guide →

Supplement & herbal interactions

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

8
Nutrient depletion considerations

Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 gPer package
Retail pharmacies payNADAC · weekly $0.138 $2.07 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.5087 $7.63 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.2669 $4.00 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.431 $0.118
▼ Down 68% 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 Per unit Per pack Marketing startMarketing endStatus
00713-0656-15 You're viewing this 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.1383 / g $2.07 2016-04-14 — Active
00713-0656-31 0713-0656-31 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.1533 / g $4.60 2016-04-14 — Active
00713-0656-37 0713-0656-37 1 TUBE in 1 CARTON / 45 g in 1 TUBE $0.1083 / g $4.87 2016-04-14 — Active
00713-0656-60 0713-0656-60 Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE $0.1146 / g $6.88 2016-04-14 — Active

Per g, this pack runs about 28% above the cheapest pack (NDC 00713-0656-37, $0.1083 vs $0.1383 NADAC).

This pack accounts for about 18% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Clobetasol Propionate .5 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clobetasol Propionate .5 mg/gthis 00713-0656-15 Cosette 1 tube $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 21922-0017-04 Encube 1 tube $0.138 AB Availability likely —
Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 Macleods 1 tube $0.138 AB Availability likely —
clobetasol propionate .5 mg/g 43386-0096-60 Lupin 1 tube $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 51672-1259-01 Sun 1 tube $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 59651-0732-14 Aurobindo 1 tube $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 62332-0465-15 Alembic 1 tube $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 70700-0106-15 Xiromed, 15 g $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 72603-0855-01 NorthStar 1 tube $0.138 AB Availability likely —
Clobetasol Propionate .5 mg/g 69238-1532-03 Amneal 1 tube $0.167 AB1 Availability likely +21%
Clobetasol Propionate .5 mg/g 51672-1258-01 Sun 1 tube $0.193 AB1 Availability likely +40%
Clobetasol Propionate .5 mg/g 70700-0109-15 Xiromed, 1 tube $0.193 AB1 Availability likely +40%
Clobetasol Propionate .5 mg/g 62332-0547-15 Alembic 1 tube $0.193 AB1 Availability likely +40%
Clobetasol Propionate .5 mg/g 13668-0569-01 Torrent 15 g $0.193 AB1 Availability likely +40%
Clobetasol Propionate .5 mg/g 00168-0163-15 E. 15 g $0.193 AB1 Availability likely +40%
Clobetasol Propionate .5 mg/g 68180-0956-01 Lupin 1 tube $0.193 AB1 Availability likely +40%
Clobetasol Propionate .5 mg/g 68462-0529-17 Glenmark 1 tube $0.224 — FDA listed +62%
Clobetasol Propionate .5 mg/g 00168-0162-15 E. 15 g $0.295 AB FDA listed +113%
Clobetasol Propionate .5 mg/g 68462-0530-17 Glenmark 1 tube $0.329 — FDA listed +138%
Clobetasol Propionate .5 mg/g 70710-1401-01 Zydus 1 tube $0.329 AB FDA listed +138%
Clobetasol Propionate .5 mg/g 16714-0782-01 Northstar 1 tube $0.329 — Discontinued +138%
Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 E. 1 tube $0.590 AB2 Discontinued +327%
Clobetasol Propionate .5 mg/g 51672-1297-01 Sun 1 tube $0.601 AB2 Availability likely +334%
Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 The 1 tube $0.601 AB2 Availability likely +334%
Clobetasol Propionate .5 mg/g 00168-0293-15 E. 15 g $0.666 AB FDA listed +381%
Clobetasol Propionate .5 mg/g 45802-0925-14 Padagis 1 tube $0.862 AB Availability likely +524%
Clobetasol Propionate .5 mg/g 51672-1294-01 Sun 1 tube $0.862 AB Availability likely +524%
clobetasol propionate .5 mg/g 40032-0096-60 Novel 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 42291-0077-15 AvKARE 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 46708-0465-15 Alembic 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-5488-00 A-S 1 tube — — FDA listed —
Clobetasol Propionate .5 mg/g 50090-6402-00 A-S 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-6731-00 A-S 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-8001-00 A-S 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2455-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2456-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2457-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2458-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 68071-3922-05 NuCare 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 68788-7963-01 Preferred 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 70771-1209-01 Zydus 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2837-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2851-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2859-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 71335-2860-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 72162-1273-02 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 50090-0549-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 50090-5079-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 50090-6717-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-8637-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-8638-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 63629-2331-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2332-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 46708-0547-15 Alembic 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 82804-0083-30 Proficient 30 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 72162-1438-02 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 72162-1961-02 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 Bryant 1 tube — AB2 FDA listed —
Clobetasol Propionate .5 mg/g 72189-0262-30 DIRECT 30 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2329-01 Bryant 60 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2330-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-8639-01 Bryant 1 tube — AB FDA listed —
Clobetasol Propionate .5 mg/g 42291-0076-15 AvKARE 1 tube — AB1 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
Jan 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.

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

  • 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.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.

3 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

LabelerCosette Pharmaceuticals, Inc.
Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC
FDA applicationANDA074089 (ANDA)
Labeler code00713
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio99 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 99 words ▾

INDICATIONS AND USAGE Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

⏱️ Dosage and Administration 98 words ▾

DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol Propionate Ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE ). Clobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g per week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved.

If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol Propionate Ointment should not be used with occlusive dressings.

⛔ Contraindications 23 words ▾

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

🤒 Adverse Reactions 135 words ▾

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported for Clobetasol Propionate Ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 212 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 to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg.

These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of Clobetasol Propionate Ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg.

These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of Clobetasol Propionate Ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women.

Clobetasol Propionate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 150 words ▾

Pediatric Use Safety and effectiveness of Clobetasol Propionate Ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing syndrome when they are treated with topical corticosteroids.

They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS ). HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of responses to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 60 words ▾

Geriatric Use Clinical studies of clobetasol propionate drug products in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

🆘 Overdosage 19 words ▾

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

🧬 Clinical Pharmacology 87 words ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .

📦 How Supplied / Storage and Handling 53 words ▾

HOW SUPPLIED Clobetasol Propionate Ointment, USP 0.05% is supplied in: 15 g tubes (NDC 0713-0656-15) 30 g tubes (NDC 0713-0656-31) 45 g tubes (NDC 0713-0656-37) 60 g tubes (NDC 0713-0656-60) Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 06/2022 8-0656CPLNC2 VC7642

📋 Description 104 words ▾

DESCRIPTION Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water.

Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 32 ClFO 5 and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. molec-struc

💬 Information for Patients 107 words ▾

Information for Patients Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. 4.

Patients should report any signs of local adverse reactions to the physician. 5. Patients should inform their physicians that they are using clobetasol propionate if surgery is contemplated.

⚠️ Precautions 1 words ▾

PRECAUTIONS

🍼 Nursing Mothers 67 words ▾

Nursing 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 Clobetasol Propionate Ointment is administered to a nursing woman.

🧬 Pharmacokinetics 93 words ▾

Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with Clobetasol Propionate Ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 88 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

📄 Package Label / Principal Display Panel 98 words ▾

PRINCIPAL DISPLAY PANEL NDC 0713-0656-15 Clobetasol Propionate Ointment,USP 0.05% 15 g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE Cosette Pharmaceuticals, Inc. NDC 0713-0656-31 Clobetasol Propionate Ointment,USP 0.05% 30 g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE Cosette Pharmaceuticals, Inc. NDC 0713-0656-37 Clobetasol Propionate Ointment,USP 0.05% 45 g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE Cosette Pharmaceuticals, Inc.

NDC 0713-0656-60 Clobetasol Propionate Ointment,USP 0.05% 60 g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE Cosette Pharmaceuticals, Inc. carton 15g carton-30g carton 45 carton 60

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
3.9K
Units reimbursed last 4 qtrs
111.7K
Gross reimbursed last 4 qtrs
$56.8K
Avg / prescription
$14.69
Avg / unit
$0.5087
Latest quarter Q1 2026
885Rx
Medicaid pays / g
$0.5087
gross reimbursed
vs
NADAC / g
$0.1383
acquisition cost
=
Spread
+$0.3704
+268% vs cost
What Medicaid paid per g (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 ⓘ
33% FFS 67% MCO
Fee-for-service · 1,266 Rx Managed care · 2,602 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,510 units · 44.9 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,305 units · 22.7 per 100k residents MN Wisconsin: 2,175 units · 36.8 per 100k residents WI Michigan: 30,180 units · 301 per 100k residents MI New York: 8,160 units · 41.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,050 units · 24.8 per 100k residents OR Nevada: 3,570 units · 112 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 2,685 units · 21.4 per 100k residents IL Indiana: 6,375 units · 92.9 per 100k residents IN Ohio: 8,235 units · 69.9 per 100k residents OH Pennsylvania: 4,635 units · 35.8 per 100k residents PA New Jersey: 1,650 units · 17.8 per 100k residents NJ Massachusetts: 330 units · 4.7 per 100k residents MA California: 13,065 units · 33.5 per 100k residents CA Utah: no data reported UT Colorado: 2,325 units · 39.6 per 100k residents CO Nebraska: no data reported NE Missouri: 2,820 units · 45.5 per 100k residents MO Kentucky: 3,795 units · 83.8 per 100k residents KY West Virginia: 1,515 units · 85.6 per 100k residents WV Virginia: 1,530 units · 17.6 per 100k residents VA Maryland: no data reported MD Connecticut: 675 units · 18.7 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,290 units · 17.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 195 units · 6.4 per 100k residents AR Tennessee: 360 units · 5.1 per 100k residents TN North Carolina: 3,135 units · 28.9 per 100k residents NC South Carolina: 1,155 units · 21.5 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 900 units · 19.7 per 100k residents LA Mississippi: 255 units · 8.7 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,890 units · 6.2 per 100k residents TX Florida: 2,910 units · 12.9 per 100k residents FL
Units reimbursed · per 100k residents
4.7301
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 Michigan 301 /100k
2 Nevada 112 /100k
3 Indiana 92.9 /100k
4 West Virginia 85.6 /100k
5 Kentucky 83.8 /100k
6 Ohio 69.9 /100k
7 Missouri 45.5 /100k
8 Washington 44.9 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube00713-0656-60 10,434 Rx · $208,308
1 tube00713-0656-31 6,047 Rx · $105,993
1 tube this page00713-0656-15 3,868 Rx · $56,812
1 tube00713-0656-37 1,521 Rx · $24,522
Drug total (last 4 qtrs): 21,870 Rx · 1,075,810 units · $395,635 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Clobetasol Propionate — the program that covers self-administered drugs. 22 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 Clobetasol Propionate. 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
$28.79M
Claims incl. refills
813.5K
Beneficiaries
629K
Spend / beneficiary
$45.78
Spend / claim
$35.39
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.
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.