Prescription medicine
Betamethasone and clotrimazole First approved as Lotrisone
Betamethasone and clotrimazole (Lotrisone) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.190 per gram (Clotrimazole-betamethasone cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the betamethasone and clotrimazole FDA label on DailyMed (effective July 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the NDA 18827 record on Drugs@FDA; every betamethasone and clotrimazole label on DailyMed.
Highlights of the record
FDA label of July 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageClotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.
Forms and strengths
- 0.5 mg/g / 10 mg/g
- 10 mg/g / 0.5 mg/g
- 10 mg/ml / 0.5 mg/ml
Cream; lotion.
On the market
- Earliest approval on file
- July 10, 1984 Lotrisone, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first May 29, 2001; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 16 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.190 per gram Clotrimazole-betamethasone cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2019 0 Class I among all firms' recalls; latest February 25, 2022
- FAERS reports
- 428 through July 30, 2026
What is betamethasone and clotrimazole used for?
From the label: indications and usageClotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. […]
Conditions named in the indications of betamethasone and clotrimazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Azole Antifungal and Corticosteroid.
Source: FDA drug label (Clotrimazole and Betamethasone Dipropionate), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective July 28, 2026 (SPL set 55db730a-df6d-4950-9c26-91b06bdcef36), via openFDA; the full label on DailyMed
What does the patient leaflet for betamethasone and clotrimazole 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 clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)?Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) should not be used to treat diaper rash or redness. You should avoid applying clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the diaper area.
From the patient leaflet: How should I store clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)?Store clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) at room temperature between 68° to 77°F (20° to 25°C) • Keep clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) and all medicines out of the reach of children.
Source: FDA drug label (Clotrimazole and Betamethasone Dipropionate), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective July 28, 2026 (SPL set 55db730a-df6d-4950-9c26-91b06bdcef36), via openFDA; the full label on DailyMed
Is there a generic for betamethasone and clotrimazole (Lotrisone)?
The FDA approved the first generic betamethasone and clotrimazole on May 29, 2001. 6 generic applications are approved; 5 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 betamethasone and clotrimazole from 16 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for betamethasone and clotrimazole (Lotrisone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.190 per gram (Clotrimazole-betamethasone cream), down 9% from $0.208 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.
- Clotrimazole-betamethasone cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clotrimazole-betamethasone cream | Generic | $0.190 per gram | n/a | -9% |
| Clotrimazole-betamethasone lot | Generic | $3.15 per mL | n/a | +17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has betamethasone and clotrimazole been recalled?
The FDA's Enforcement Report lists 2 recalls naming betamethasone and clotrimazole since 2019: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 25, 2022 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample |
| August 7, 2019 | Class III | Glenmark Pharmaceuticals Inc., USA | Temperature Abuse: Complaints received of liquidy texture. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the betamethasone and clotrimazole label say about other medicines?
The betamethasone and clotrimazole label names 1 other medicine in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Cosyntropin | warnings and precautions | One of these subjects had an abnormal cosyntropin test. |
Check betamethasone and clotrimazole against other medicines
Source: FDA drug label (Clotrimazole and Betamethasone Dipropionate), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective July 28, 2026 (SPL set 55db730a-df6d-4950-9c26-91b06bdcef36), via openFDA; the full label on DailyMed
What do FAERS reports show for betamethasone and clotrimazole?
The FDA Adverse Event Reporting System holds 428 reports that list betamethasone and clotrimazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 34 are coded as a death and 105 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.
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 betamethasone and clotrimazole?
17 other medicines are given the same way (topical) and in the same FDA class as betamethasone and clotrimazole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 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 |
|---|---|---|---|---|
| Miconazole | Fungal infections | none listed | $0.120 per gram 2% topical cream | No current entry |
| Ketoconazole | Fungal infections | 25 labelers | $0.249 per gram 2% cream | No current entry |
| Nystatin and triamcinolone | Fungal infections | 18 labelers | $0.225 per gram Nystatin-triamcinolone cream | No current entry |
| Econazole | Fungal infections | 6 labelers | $0.351 per gram 1% cream | No current entry |
| Sulconazole | Fungal infections | none listed | n/a | A presentation being discontinued |
| Oxiconazole | Fungal infections | 1 labeler | $3.92 per gram 1% cream | No current entry |
| Luliconazole | Fungal infections | none listed | n/a | No current entry |
| Miconazole and petrolatum and zinc oxide | Fungal infections | none listed | $9.12 per gram 0.25-15% | No current entry |
Every medicine labeled for the same conditions as betamethasone and clotrimazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to betamethasone and clotrimazole
- 17 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Betamethasone and clotrimazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other