Hydrocortisone Valerate 2 mg/g Ointment — NDC 0713-0560-15 (Billing 00713-0560-15)
This is a package of Hydrocortisone Valerate 2 mg/g Ointment from Cosette Pharmaceuticals, Inc., marketed since May 2021 and currently FDA-listed; retail pharmacies pay about $2.29 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007533
- GCN: 06040
- GPI-14 (Medi-Span): 90550075204205
- HICL (First Databank): 003298
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1370750
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
- Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
- Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
- Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
Patient education
Supplement & herbal interactions
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $2.294 | $34.40 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.6643 | $9.96 / 15 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00713-0560-15 You're viewing this Main listing | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $2.29 / g | $34.40 | 2021-05-03 | — | Active |
| 00713-0560-37 0713-0560-37 | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | $1.58 / g | $71.03 | 2021-05-03 | — | Active |
| 00713-0560-60 0713-0560-60 | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $1.16 / g | $69.63 | 2021-05-03 | — | Active |
Per g, this pack runs about 98% above the cheapest pack (NDC 00713-0560-60, $1.16 vs $2.29 NADAC).
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Hydrocortisone Valerate 2 mg/g Ointment?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocortisone Valerate 2 mg/g 00713-0720-15 | Cosette | 1 tube | $0.374 | AB | Availability likely | save 84% |
| Hydrocortisone Valerate 2 mg/g 51672-1290-01 | Sun | 1 tube | $0.374 | AB | Availability likely | save 84% |
| Hydrocortisone Valerate 2 mg/g 68180-0954-01 | Lupin | 1 tube | $0.374 | AB | Availability likely | save 84% |
| Hydrocortisone Valerate 2 mg/gthis 00713-0560-15 | Cosette | 1 tube | $2.294 | AB | Availability likely | — |
| Hydrocortisone Valerate 2 mg/g 51672-1292-01 | Sun | 1 tube | $2.294 | AB | Availability likely | — |
| Hydrocortisone Valerate 2 mg/g 68462-0836-17 | Glenmark | 1 tube | $2.796 | — | FDA listed | +22% |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
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UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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UNII 4OH5W9UM87
A synthetic emulsifier and surfactant derived from stearic acid. It helps oils and water mix together in liquid medicines and creams, and improves how the product spreads and feels on the skin.
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UNII V56DFE46J5
Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
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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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hydrocortisone valerate ointment USP, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Hydrocortisone valerate ointment USP, 0.2% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Hydrocortisone valerate ointment USP, 0.2% should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate ointment USP, 0.2% should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.
⛔ Contraindications ▾
CONTRAINDICATIONS Hydrocortisone valerate ointment USP, 0.2% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of hydrocortisone valerate ointment USP, 0.2% was approximately 12%. These included worsening of condition (2%), transient itching (2%), irritation (1%) and redness (1%). In controlled clinical studies involving pediatric atopic dermatitis patients 2 through 12 years of age (n=64), the incidence of adverse experiences was approximately 28.1%, which is higher than that seen in adult patients.
Reported reactions included eczema (12.5%), pruritis (6%), stinging (2%), and dry skin (2%). Patients were not specifically evaluated for signs of atrophy (thinning, telangiectasia, erythema). No studies were performed to assess adrenal suppression and/or growth suppression.
The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Dermal embryofetal developmental studies were conducted in rabbits and rats with hydrocortisone valerate cream, 0.2%.
Hydrocortisone valerate cream, 0.2%, was administered topically for 4 hours/day, rather than the preferred 24 hours/day, during the period of organogenesis in rats (gestational days 5-16) and rabbits (gestational days 6-19). Topical doses of hydrocortisone valerate up to 9 mg/kg/day (54 mg/m 2 /day) were administered to rats and 5 mg/kg/day (60 mg/m 2 /day) were administered to rabbits. In the absence of maternal toxicity, a significant increase in delayed skeletal ossification in fetuses was noted at 9 mg/kg/day [2.5X the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA) comparisons] in the rat study.
No malformations in the fetuses were noted at 9 mg/kg/day (2.5X MRHD based on BSA comparisons) in the rat study. Indicators of embryofetal toxicity, significant decrease in fetal weight at 2 mg/kg/day (1X MRHD based on BSA) and a significant increase in post-implantation loss and embryo resorption at 5 mg/kg (3X MRHD based on BSA), were noted in the rabbit study. A significant increase in delayed skeletal ossification in fetuses was noted at 5 mg/kg/day (3X the MRHD based on BSA comparisons) in the rabbit study.
Increased numbers of fetal malformations (e.g., cleft palate, omphalocele and clubbed feet) were noted at 5 mg/kg/day (3X MRHD based on BSA comparisons) in the rabbit study. There are no adequate and well-controlled studies in pregnant women. Hydrocortisone valerate ointment USP, 0.2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety of this product in pediatric patients has not been established. There is no data on adrenal suppression and/or growth suppression. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids.
They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS ) HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of hydrocortisone valerate ointment USP, 0.2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Topically applied hydrocortisone valerate ointment USP, 0.2% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Like other topical corticosteroids, hydrocortisone valerate has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier.
Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Studies performed with hydrocortisone valerate ointment USP, 0.2% indicate that it is in the medium range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocortisone valerate ointment USP, 0.2% is supplied in the following tube sizes: 15 g NDC 0713-0560-15 45 g NDC 0713-0560-37 60 g NDC 0713-0560-60 STORAGE Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0560CPLNC2 Rev. 10/2022 VC7690
📦 Storage and Handling ▾
STORAGE Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0560CPLNC2 Rev. 10/2022 VC7690
📋 Description ▾
DESCRIPTION Hydrocortisone valerate ointment USP, 0.2%, contains hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26 H 38 O 6 .
It has the following structural formula: Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer 974P, sodium phosphate dibasic anhydrous, methylparaben, light mineral oil, propylene glycol, purified water, sodium lauryl sulfate, steareth-2, steareth-100, stearyl alcohol, and white petrolatum. structure
💬 Information for Patients ▾
Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions.
Hydrocortisone valerate ointment USP, 0.2% should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressings. (See DOSAGE AND ADMINISTRATION .) This medication should not be used on the face, underarms, or groin areas unless directed by the physician. As with other corticosteroids, therapy should be discontinued when control is achieved.
If no improvement is seen within 2 weeks, contact the physician.
⚠️ Precautions ▾
PRECAUTIONS General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Hydrocortisone valerate ointment USP, 0.2% has produced mild, reversible adrenal suppression in adult patients when used under occlusion for 5 days, 15 grams twice a day over 25 to 60% body surface area or when used three times a day over 20 to 30% body surface area to treat psoriasis for 3-4 weeks. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for these products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS -- Pediatric Use ). If irritation develops, hydrocortisone valerate ointment USP, 0.2% should be discontinued and appropriate therapy instituted.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.
If a favorable response does not occur promptly, use of hydrocortisone valerate ointment USP, 0.2% should be discontinued until the infection has been adequately controlled. Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
Patients should report to their physician any signs of local adverse reactions. Hydrocortisone valerate ointment USP, 0.2% should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressings. (See DOSAGE AND ADMINISTRATION .) This medication should not be used on the face, underarms, or groin areas unless directed by the physician.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of hydrocortisone valerate.
Hydrocortisone valerate ointment USP, 0.2% was shown to be non-mutagenic in the Ames-Salmonella/Microsome Plate Test. There are no studies which assess the effects of hydrocortisone valerate on fertility and general reproductive performance. Pregnancy Teratogenic Effects Pregnancy Category C Corticostero… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when hydrocortisone valerate ointment USP, 0.2% is administered to a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with hydrocortisone valerate ointment USP, 0.2% indicate that it is in the medium range of potency as compared with other topical corticosteroids.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of hydrocortisone valerate. Hydrocortisone valerate ointment USP, 0.2% was shown to be non-mutagenic in the Ames-Salmonella/Microsome Plate Test. There are no studies which assess the effects of hydrocortisone valerate on fertility and general reproductive performance.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0713- 0560 -15 Hydrocortisone Valerate Ointment, USP Rx only 0.2% 15 g FOR TOPICAL USE ONLY. NOT FOR USE IN EYES. NDC 0713- 0560 -37 Hydrocortisone Valerate Ointment, USP Rx only 0.2% 45 g FOR TOPICAL USE ONLY. NOT FOR USE IN EYES. NDC 0713- 0560 -60 Hydrocortisone Valerate Ointment, USP Rx only 0.2% 60 g FOR TOPICAL USE ONLY. NOT FOR USE IN EYES. 15g carton 45g carton 60g carton