Prescription and over-the-counter medicine
Hydrocortisone Brand names: Solu-Cortef, Alkindi, Cortef, Khindivi, Cortifoam; first approved as Hydrocortone
Hydrocortisone (Solu-Cortef) is a prescription and over-the-counter medicine with an FDA approval on record since 1951. FDA's NDC Directory lists it from 49 generic labelers, and pharmacies paid $0.0613 per gram (Hydrocortisone 1% cream) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $51.43 per Solu-cortef 250 mg act-o-vial.
- Generic listed
- A presentation discontinued
Check it at the source: the hydrocortisone FDA label on DailyMed (effective August 19, 2026); the NDA 8228 record on Drugs@FDA; every hydrocortisone label on DailyMed.
Highlights of the record
FDA label of August 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
seborrheic dermatitis
cosmetics
soaps
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor
Forms and strengths
- 0.5 mg
- 1 mg
- 2 mg
- 5 mg
- 10 mg
- 20 mg
- 1 mg/ml
- 1 mg/g
- 2 mg/g
- 10 mg/g
- 20 mg/ml
- 20 mg/g
Cream; tablet; ointment; lotion; injection (powder) for solution.
On the market
- Earliest approval on file
- December 21, 1951 Hydrocortone, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 131 first December 22, 1971; 39 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 57 of which 49 under generic applications, 8 under brand applications, repackagers included; 188 more under the over-the-counter monograph, without an application
- Last listed patent
- February 23, 2043 Khindivi oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0613 per gram Hydrocortisone 1% cream
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest April 13, 2022; 10 more by firms not listed as its makers
- FAERS reports
- 97,782 through July 30, 2026
What is hydrocortisone used for?
From the label: indications and usagetemporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
seborrheic dermatitis
cosmetics
soaps
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor
Conditions named in the indications of hydrocortisone's FDA labels, with every medicine labeled for each:
- Osteoarthritis
- Asthma
- Allergies
- Herpes and shingles
- Leukemia, lymphoma and myeloma
- Crohn's disease and ulcerative colitis
- Eczema (atopic dermatitis)
From other hydrocortisone labelsOsteoarthritis: … subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.
Asthma and Allergies: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6.
Herpes and shingles: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic …
Leukemia, lymphoma and myeloma: Leukemias and lymphomas in adults Acute leukemia of childhood 10.
Crohn's disease and ulcerative colitis: Ulcerative colitis Regional enteritis 12.
Eczema (atopic dermatitis): The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (hydrocortisone 1), Kroger Company, effective August 19, 2026 (SPL set f05edff2-2dc5-427c-b52c-518e0aaef4e0), via openFDA; the full label on DailyMed
What does the patient leaflet for hydrocortisone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ALKINDI SPRINKLE?ALKINDI SPRINKLE may cause serious side effects, including: Adrenal gland problems. Not giving enough ALKINDI SPRINKLE, stopping ALKINDI SPRINKLE, or switching to ALKINDI SPRINKLE after taking another hydrocortisone medicine (the same class of medicines as ALKINDI SPRINKLE) by mouth, can cause serious and life-threatening adrenal gland problems including death. Do not stop giving ALKINDI SPRINKLE without talking to your healthcare provider. Tell your healthcare provider if your child has any of these symptoms: loss of appetite joint pain low blood sugar fatigue nausea feeling lightheaded or dizzy weakness vomiting problems with body salt (electrolyte) levels Your healthcare provider will change the dose of ALKINDI SPRINKLE depending on your child’s size. Tell your healthcare provider if your child cannot swallow medicines by mouth. During episodes of acute infections, surgery, major trauma or if your child cannot take medicines by mouth, your healthcare provider may recommend increased doses of ALKINDI SPRINKLE or use of corticosteroid medicines given directly into the bloodstream instead. The amount of hydrocortisone in a dose of ALKINDI SPRINKLE may not be the same as in previous hydrocortisone medicines that your child takes by mouth if these oral hydrocortisone medicines have been changed (for example, crushed or compounded). When switching to ALKINDI SPRINKLE, your healthcare provider may need to prescribe a starting dose of ALKINDI SPRINKLE that is different from previous hydrocortisone medicines that your child may have been taking by mouth. Watch your child closely after being switched to ALKINDI SPRINKLE and contact your healthcare provider if your child has any symptoms of adrenal gland problems. […]
From the patient leaflet: How should I store ALKINDI SPRINKLE?Store ALKINDI SPRINKLE at room temperature between 68°F to 77°F (20°C to 25°C). Store in the original bottle to protect from light. After the bottle has been opened, use the ALKINDI SPRINKLE capsules within 60 days. Keep ALKINDI SPRINKLE and all medicines out of the reach of children.
Source: FDA drug label (Alkindi Sprinkle), Eton Pharmaceuticals, Inc., effective April 21, 2026 (SPL set 26c13a5f-7119-4c6a-bf10-fda4e07d7682), via openFDA; the full label on DailyMed
Is there a generic for hydrocortisone (Solu-Cortef)?
The FDA approved the first generic hydrocortisone on December 22, 1971. 131 generic applications are approved; 39 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 hydrocortisone from 49 labelers under a generic (ANDA) application and from 8 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 Solu-Cortef injection; a patent listed only for Khindivi oral solution runs to February 23, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1951 earliest approval on file
- 1971 first generic approved
- 2043 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 hydrocortisone (Solu-Cortef)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0613 per gram (Hydrocortisone 1% cream), up 1% from $0.0605 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Hydrocortisone 1% cream (generic)
- Solu-cortef 250 mg act-o-vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft itch relief 1% ointment | Generic | $0.077 per gram | n/a | +0.2% |
| Ft itch rlf with aloe 1% cream | Generic | $0.0716 per gram | n/a | +0.2% |
| Gs anti-itch 1% cream | Generic | $0.0613 per gram | n/a | +1% |
| Hydrocortisone 0.5% cream | Generic | $0.0816 per gram | n/a | +6% |
| Hydrocortisone 1% cream | Generic | $0.0613 per gram | n/a | +1% |
| Hydrocortisone 1% ointment | Generic | $0.077 per gram | n/a | +0.2% |
| Hydrocortisone 10 mg tablet | Generic | $0.180 per tablet | $5.39 | -21% |
| Hydrocortisone 100 mg/60 mL | Generic | $0.141 per mL | n/a | -7% |
| Hydrocortisone 2.5% cream | Generic | $0.102 per gram | n/a | -8% |
| Hydrocortisone 2.5% lotion | Generic | $0.222 per mL | n/a | +2% |
| Hydrocortisone 2.5% ointment | Generic | $0.0955 per gram | n/a | -3% |
| Hydrocortisone 20 mg tablet | Generic | $0.301 per tablet | $9.02 | -28% |
| Hydrocortisone 5 mg tablet | Generic | $0.139 per tablet | $4.17 | -6% |
| Hydrocortisone buty 0.1% cream | Generic | $2.38 per gram | n/a | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is hydrocortisone in shortage?
No hydrocortisone presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated July 23, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Hydrocortisone Acetate, Suppository, 25 mg (NDC 0574-7090-12) | Padagis US LLC | To Be Discontinued | July 23, 2026 |
| Hydrocortisone Acetate, Suppository, 30 mg (NDC 0574-7093-12) | Padagis US LLC | To Be Discontinued | July 23, 2026 |
Every hydrocortisone presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has hydrocortisone been recalled?
The FDA's Enforcement Report lists 17 recalls naming hydrocortisone since 2013: 0 Class I (the most serious), 16 Class II, 1 Class III; 0 still ongoing. 10 of them are by firms that FDA's NDC Directory does not list as a maker of hydrocortisone and that hold 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 |
|---|---|---|---|
| April 24, 2025 | Class II | KENIL HEALTHCARE PRIVATE LIMITED not a listed maker | CGMP Deviations |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 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. |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| July 13, 2020 | Class II | Bausch Health Companies, Inc. | SUBPOTENT DRUG |
| July 11, 2019 | Class II | US Pharmaceuticals Inc. not a listed maker | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing … |
| December 7, 2018 | Class II | US Pharmaceuticals Inc. not a listed maker | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample |
| May 7, 2018 | Class II | Perrigo New York | Failed Stability Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrocortisone label say about other medicines?
The hydrocortisone label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name hydrocortisone. 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 |
|---|---|---|
| Amphotericin b | drug interactions | Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. |
| Aspirin | drug interactions | Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. |
| Carbamazepine | drug interactions | Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin): Drugs that induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. |
| Cholestyramine | drug interactions | Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. |
| Clarithromycin | drug interactions | CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the … Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin Antiretrovirals: ritonavir Grapefruit juice |
| Cosyntropin | warnings and precautions (prescription label) | This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). |
| Cyclosporine | drug interactions | Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. |
| Efavirenz | drug interactions | Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal … and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing Products |
| Erythromycin | drug interactions | Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin): |
| Isoniazid | drug interactions | Antitubercular drugs: Serum concentrations of isoniazid may be decreased. |
| Itraconazole | drug interactions | CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the … Intervention: Concomitant use of CYP3A4 inhibitors may require a decrease in the ALKINDI SPRINKLE dose. Examples: Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin … |
| Ketoconazole | drug interactions | Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin): |
| Nevirapine | drug interactions | Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal … Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing Products |
| Oxcarbazepine | drug interactions | Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal … Intervention: Concomitant use of CYP3A4 inducers may require an increase in the ALKINDI SPRINKLE dose. Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates … |
Every other medicine the hydrocortisone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenobarbital | drug interactions | Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal … carbamazepine and oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing Products |
| Phenytoin | drug interactions | Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin): Drugs that induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids and require that … |
| Posaconazole | drug interactions | CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the … Intervention: Concomitant use of CYP3A4 inhibitors may require a decrease in the ALKINDI SPRINKLE dose. Examples: Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin … |
| Primidone | drug interactions | Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal … oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing Products |
| Rifabutin | drug interactions | Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal … Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing … |
| Rifampin | drug interactions | Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin): Drugs that induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids and require that … |
| Ritonavir | drug interactions | CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the … voriconazole Antibiotics: erythromycin and clarithromycin Antiretrovirals: ritonavir Grapefruit juice |
| Voriconazole | drug interactions | CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the … Intervention: Concomitant use of CYP3A4 inhibitors may require a decrease in the ALKINDI SPRINKLE dose. Examples: Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin … |
| Warfarin | drug interactions | Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. |
Other labels that name hydrocortisone
Source: FDA drug label (hydrocortisone 1), Kroger Company, effective August 19, 2026 (SPL set f05edff2-2dc5-427c-b52c-518e0aaef4e0), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrocortisone?
The FDA Adverse Event Reporting System holds 97,782 reports that list hydrocortisone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,336 are coded as a death and 39,835 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 hydrocortisone?
4 other medicines are given the same way (topical) and in the same FDA class as hydrocortisone or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Fluocinolone | Eczema (atopic dermatitis) | 15 labelers | $0.171 per mL 0.01% scalp oil | No current entry |
| Desonide | Eczema (atopic dermatitis) | 12 labelers | $0.252 per gram 0.05% cream | No current entry |
| Fluticasone | Eczema (atopic dermatitis) | 8 labelers | $0.243 per gram 0.05% cream | No current entry |
| Dexamethasone | Eczema (atopic dermatitis) | none listed | n/a | In shortage |
Every medicine labeled for the same conditions as hydrocortisone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does hydrocortisone compare with medicines for the same use?
13 side-by-side pages set hydrocortisone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to hydrocortisone
- 4 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Hydrocortisone side effects
- the label's list beside FAERS reports
- Hydrocortisone shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other