Hydrocortisone is a corticosteroid sold in the U.S. under 14 brand and generic names, for contact dermatitis, facial dermatoses and foot dermatoses. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Alkindi Sprinkle (application NDA213876). Other hydrocortisone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Individualize the dose, using the lowest possible dosage. (2.1) • The recommended starting replacement dosage is 8 to 10 mg/m2 daily. Higher doses may be needed based on patient’s age and symptoms of the disease. Use of lower starting doses may be sufficient in patients with residual but decreased endogenous cortisol production. (2.1) • Round the dose to the nearest 0.5 mg or 1 mg. More than one capsule may be needed to supply the required dose. (2.1) • Divide the total daily dose in 3 doses and administer 3 times daily. Older patients may have their daily dose divided by 2 and administered twice daily. (2.1) • When switching from other oral hydrocortisone formulations, use the same total daily hydrocortisone dosage. If symptoms of adrenal insufficiency occur, increase total daily dosage. (2.2) • ALKINDI SPRINKLE are oral granules contained within capsules. Do not swallow the capsule. Do not chew or crush the granules. (2.3) • See the Full Prescribing Information for detailed administration instructions. (2.3) 2.1 Dosage Information Individualize the dose for each patient, using the lowest possible dosage. The recommended starting replacement dosage is 8 to 10 mg/m 2 /day daily. Higher doses may be needed based on patient’s age and symptoms of the disease. Use of lower starting doses may be sufficient in patients with residual but decreased…
The following serious adverse reactions are described here and elsewhere in the label: Adrenal Crisis [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement [see Warnings and Precautions ( 5.2 )] Growth Retardation [see Warnings and Precautions ( 5.3 )] Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids [see Warnings and Precautions ( 5.4 )] Decrease in Bone Mineral Density [see Warnings and Precautions ( 5.5 )] Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.7 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.8 )] Risk of Kaposi's Sarcoma with Use of Dosage Greater Than Replacement [see Warnings and Precautions (5.9)] Vaccinations [see Warnings and Precautions (5.10)] Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | Generic | $0 | View → | |
| 2 | 70/100 | Prescription | Enema | Generic |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for:…
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for…
CGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Essential Calming Skin Gel
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net…
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Sk…
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ALKINDI SPRINKLE is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. Anaphylactic reactions have occurred in patients receiving corticosteroids [see Adverse Reactions ( 6.2 )] . Hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. ( 4 )
Table 2 Drug Interactions with ALKINDI SPRINKLE 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 use of excessive doses. 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 Antiretrovirals: ritonavir Grapefruit juice CYP3A4 Inducers 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 crisis. Intervention: Concomitant use of CYP3A4 inducers may require an increase in the ALKINDI SPRINKLE dose. Examples: Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing Products Clinical Impact: Oral estrogen and estrogen-containing oral contraceptives may interact with hydrocortisone by increasing serum cortisol-binding globulin (CBG)…
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| 3 | 56/100 | Prescription | Tablet | Generic | $0 | View → |
| 4 | 54/100 | Prescription | Topical | — | — | View → |
| 5 | Not yet rated | Prescription | Topical | Generic | $0 | View → |
| 6 | Not yet rated | Prescription | Powder | Generic | $0 | View → |
| 7 | Not yet rated | Prescription | Topical | Generic | $0 | View → |
| 8 | Not yet rated | Prescription | Tablet | Generic | $0 | View → |
| 9 | Not yet rated | Prescription | Topical | Generic | $0 | View → |
| 10 | Not yet rated | Prescription | Spray/Inhaler | Generic | $0 | View → |