Prescription medicine
Clobetasol Brand names: Byqlovi, Impoyz, Clodan, Tovet; first approved as Temovate
Clobetasol (Temovate) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.126 per gram (Clobetasol 0.05% ointment) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the clobetasol FDA label on DailyMed (effective April 21, 2026, Encube Ethicals, Inc.); the NDA 19323 record on Drugs@FDA; every clobetasol label on DailyMed.
Highlights of the record
FDA label of April 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageClobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.
Forms and strengths
- 0.05 g/100ml
- 0.05 g/ml
- 0.25 mg/g
- 0.4625 mg/ml
- 0.5 mg/g
- 0.5 mg/ml
Cream; ointment; solution; shampoo; aerosol (foam).
On the market
- Earliest approval on file
- December 27, 1985 Temovate, Fougera; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 87 first February 16, 1994; 52 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 44 of which 39 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 9, 2036 Byqlovi suspension/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.126 per gram Clobetasol 0.05% ointment
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 18 since 2013 1 Class I among all firms' recalls; latest August 3, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 10,472 through July 30, 2026
What is clobetasol used for?
From the label: indications and usageClobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
Conditions named in the indications of clobetasol's FDA labels, with every medicine labeled for each:
From other clobetasol labelsPsoriasis: IMPOYZ Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.
Pain: BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (CLOBETASOL PROPIONATE), Encube Ethicals, Inc., effective April 21, 2026 (SPL set 8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65), via openFDA; the full label on DailyMed
What does the patient leaflet for clobetasol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using clobetasol propionate topical spray?Clobetasol propionate topical spray is flammable. Avoid heat, flames or smoking while applying clobetasol propionate topical spray to your skin.
From the patient leaflet: How should I store clobetasol propionate topical spray?Store clobetasol propionate topical spray at room temperature between 68°F to 77°F (20°C to 25°C). Do not store clobetasol propionate topical spray above 86°F (30°C). Do not freeze or refrigerate clobetasol propionate topical spray. Keep the bottle of clobetasol propionate topical spray tightly closed. Keep away from heat or flame. Keep clobetasol propionate topical spray and all medicines out of the reach of children.
Source: FDA drug label (CLOBETASOL PROPIONATE), Alembic Pharmaceuticals Inc., effective July 17, 2026 (SPL set a83d212b-a970-4ee7-8431-fead6b2e7f9d), via openFDA; the full label on DailyMed
Is there a generic for clobetasol (Temovate)?
The FDA approved the first generic clobetasol on February 16, 1994. 87 generic applications are approved; 52 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clobetasol from 39 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Temovate cream; a patent listed only for Byqlovi suspension/drops runs to May 9, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 1994 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clobetasol (Temovate)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.126 per gram (Clobetasol 0.05% ointment), down 23% from $0.165 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clobetasol 0.05% ointment (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clobetasol 0.05% cream | Generic | $0.167 per gram | n/a | -6% |
| Clobetasol 0.05% gel | Generic | $0.476 per gram | n/a | -48% |
| Clobetasol 0.05% ointment | Generic | $0.126 per gram | n/a | -23% |
| Clobetasol 0.05% shampoo | Generic | $0.233 per mL | n/a | -1% |
| Clobetasol 0.05% solution | Generic | $0.136 per mL | n/a | -26% |
| Clobetasol 0.05% topical lotn | Generic | $0.299 per mL | n/a | +0.1% |
| Clobetasol emollient 0.05% cream | Generic | $0.601 per gram | n/a | -6% |
| Clobetasol emollnt 0.05% foam | Generic | $2.01 per gram | n/a | +5% |
| Clobetasol emulsion 0.05% foam | Generic | $2.01 per gram | n/a | +5% |
| Clobetasol prop 0.05% foam | Generic | $0.355 per gram | n/a | +0.6% |
| Clobetasol prop 0.05% spray | Generic | $0.304 per mL | n/a | -14% |
| Clodan 0.05% shampoo | Generic | $0.233 per mL | n/a | -1% |
| Tovet emollient 0.05% foam | Generic | $1.79 per gram | n/a | -4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clobetasol been recalled?
The FDA's Enforcement Report lists 19 recalls naming clobetasol since 2013: 1 Class I (the most serious), 9 Class II, 9 Class III; 3 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of clobetasol and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 3, 2026 | Class II | Lupin Pharmaceuticals Inc. | Failed content uniformity specifications. |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| January 20, 2023 | Class III | Lupin Pharmaceuticals Inc. | Subpotent Drug: Low assay result observed during long-term stability testing. |
| March 15, 2022 | Class II | Teligent Pharma, Inc. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| December 15, 2021 | Class I | Taro Pharmaceuticals U.S.A., Inc. | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria |
| July 24, 2020 | Class III | Golden State Medical Supply Inc. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. |
| July 20, 2020 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. |
| November 15, 2019 | Class III | Glenmark Pharmaceuticals Inc., USA | Defective delivery system; product is not foaming or is coming out as liquid. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clobetasol label say about other medicines?
The clobetasol label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name clobetasol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorescein | warnings and precautions | The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. |
Source: FDA drug label (CLOBETASOL PROPIONATE), Encube Ethicals, Inc., effective April 21, 2026 (SPL set 8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65), via openFDA; the full label on DailyMed
What do FAERS reports show for clobetasol?
The FDA Adverse Event Reporting System holds 10,472 reports that list clobetasol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 434 are coded as a death and 2,015 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clobetasol?
11 other medicines are given the same way (topical) and in the same FDA class as clobetasol or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Betamethasone | Psoriasis | 26 labelers | $0.418 per gram 0.05% cream | No current entry |
| Fluocinolone | Psoriasis | 15 labelers | $0.171 per mL 0.01% scalp oil | No current entry |
| Desoximetasone | Psoriasis | 13 labelers | $0.369 per gram 0.25% ointment | No current entry |
| Halobetasol | Psoriasis | 6 labelers | $0.620 per gram 0.05% ointmnt | No current entry |
| Betamethasone and calcipotriene | Psoriasis | 5 labelers | $1.81 per gram 0.005%-0.064% ointment | No current entry |
| Halobetasol and tazarotene | Psoriasis | none listed | n/a | No current entry |
| Coal tar | Psoriasis | none listed | $0.0088 per mL 0.5% shampoo | No current entry |
| Tazarotene | Psoriasis | 6 labelers | $6.11 per gram 0.1% gel | No current entry |
Every medicine labeled for the same conditions as clobetasol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clobetasol compare with medicines for the same use?
6 side-by-side pages set clobetasol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to clobetasol
- 11 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Clobetasol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other