Hydrocortisone 25 mg/g Cream, 454 g
Past resolved recalls for this product (1)
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone 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 ↗- It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
- What exactly is this cream supposed to do for my skin?
- That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
- How long can I keep using it? Is it okay to use every day long-term?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Hydrocortisone — tap one for details:
Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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UNII 8CRQ2TH63M
Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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UNII I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
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UNII 13A4J4NH9I
A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
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UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.108 | $48.81 / 454 g |
| Medicaid paysCMS SDUD · 12 mo | $0.1113 | $50.53 / 454 g |
| Medicare drug plans payPart D · Q2 2026 | $0.1782 | $80.90 / 454 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocortisone 25 mg/g 00168-0146-16 | E. | 454 g | $0.099 | AT | FDA listed | save 8% |
| Hydrocortisone 25 mg/gthis 00168-0080-16 | E. | 454 g | $0.107 | AT | Availability likely | — |
| Hydrocortisone 25 mg/g 45802-0014-02 | Padagis | 1 tube | $0.123 | AT | Availability likely | +14% |
| Hydrocortisone 25 mg/g 45802-0004-02 | Padagis | 1 tube | $0.125 | AT | Availability likely | +16% |
| Hydrocortisone 25 mg/g 00472-0337-20 | Actavis | 1 tube | $0.125 | — | Discontinued | +17% |
| Hydrocortisone 25 mg/g 62559-0431-30 | ANI | 1 tube | $0.237 | AT | Availability likely | +120% |
| Proctozone-Hc 25 mg/g 64980-0324-30 | Rising | 1 tube | $0.237 | AT | Availability likely | +120% |
| Procto-Med HC 25 mg/g 69315-0312-28 | Leading | 1 tube | $0.237 | AT | Availability likely | +120% |
| Proctosol-HC 25 mg/g 10631-0407-01 | Sun | 1 tube | $0.546 | AT | Availability likely | +408% |
| Alacort 25 mg/g 00316-0128-16 | Crown | 454 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 00316-0193-16 | Crown | 1 jar | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-0244-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-0350-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-2452-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-5999-00 | A-S | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 25 mg/g 51672-3003-00 | Sun | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 61919-0364-30 | DIRECT | 30 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63187-0480-20 | Proficient | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-1952-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctozone-Hc 25 mg/g 63629-2396-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-8666-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-8667-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctozone-Hc 25 mg/g 63629-8847-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Anusol HC 25 mg/g 65649-0401-30 | Salix | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 66267-0967-01 | NuCare | 30 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68071-2233-01 | NuCare | 1 tube | — | AT | FDA listed | — |
| Procto-Med HC 25 mg/g 68071-3968-01 | NuCare | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68071-4511-02 | NuCare | 20 g | — | — | FDA listed | — |
| Proctozone-Hc 25 mg/g 68788-7091-03 | Preferred | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68788-8302-03 | Preferred | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68788-8583-02 | Preferred | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 68788-9922-03 | Preferred | 1 tube | — | AT | Discontinued | — |
| Hydrocortisone 25 mg/g 70518-3078-00 | REMEDYREPACK | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 71335-2954-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 72162-1382-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 72162-1764-03 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctozone-Hc 25 mg/g 72162-1805-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Proctosol-HC 25 mg/g 72162-2165-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone Cream 25 mg/g 72189-0554-28 | Direct_Rx | 20 g | — | AT | FDA listed | — |
| Hydrocortisone Cream 25 mg/g 72189-0625-30 | Direct_Rx | 1 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 82804-0135-28 | Proficient | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 85766-0081-30 | Sportpharm | 30 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 85766-0085-30 | Sportpharm | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-8817-01 | Bryant | 29 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 82804-0084-20 | Proficient | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 50090-0527-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-2527-01 | Bryant | 454 g | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 72162-1383-04 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-9057-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 63629-2528-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Hydrocortisone 25 mg/g 21922-0065-05 | Encube | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00168-0080-16 You're viewing this | 454 g in 1 JAR (0168-0080-16) | $0.1075 / g | $48.80 | 1996-12-16 | Active |
| 00168-0080-31 | 30 g in 1 TUBE (0168-0080-31) | $0.0921 / g | $2.76 | 1986-12-16 | Active |
You're viewing the largest of 2 pack sizes for this product.
Per g, this pack runs about 17% above the cheapest pack (30 g, $0.0921 vs $0.1075 NADAC).
This pack accounts for about 5.0% of this product's recent Medicaid fills; most go to the 30 gs pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00168-0080-16?
What is the difference between NDC 00168-0080-16 and NDC 00168-0080-31?
What NDC number is used to bill for this package of Hydrocortisone 25 mg/g Cream?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects –Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
🧒 Pediatric Use ▾
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTION S ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics : The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocortisone Cream USP, 2.5% Hydrocortisone Ointment USP, 2.5% a white cream is available as follows: a white ointment is available as follows: NDC 0168-0080-31 30 g Tubes NDC 0168-0146-30 28.35 g (1 oz) Tubes NDC 0168-0080-16 453.6 g (1 Lb) Jars NDC 0168-0146-16 453.6 g (1 Lb) Jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 Rev. 07/2024
📋 Description ▾
DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone Cream USP, 2.5% and Hydrocortisone Ointment USP, 2.5% contains hydrocortisone, USP. Hydrocortisone is a white to practically white crystalline powder.
Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is: Molecular Formula: C 21 H 30 O 5 Molecular Weight: 362.47 Each gram of the 2.5% Cream contains 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Each gram of the 2.5% Ointment contains 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. chemical-structure
💬 Information for Patients ▾
Information for the Patient: 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. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. 4.
Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.