Epifoam pramoxine hydrochloride and hydrocortisone acetate 100 mg/10g; 100 mg/10g Aerosol, Foam — NDC 0037-6824-10 (Billing 00037-6824-10)
This is a package of Epifoam pramoxine hydrochloride and hydrocortisone acetate 100 mg/10g; 100 mg/10g Aerosol, Foam from Viatris Specialty LLC, marketed since Aug 2014 and currently FDA-listed; retail pharmacies pay about $10.00 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0037-6824-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0037 labeler · 6824 product · 10 package
- Package marketed since
- Aug 25, 2014
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0037682410 2
- FDA record last changed
- Jul 24, 2026
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): 007062
- GCN: 84070
- GPI-14 (Medi-Span): 90559802403910
- HICL (First Databank): 015163
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 904782
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Local anesthetics class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 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 ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 | $10.000 | $100.00 / 10 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00037-6824-10 You're viewing this Main listing | 1 CANISTER in 1 CARTON / 10 g in 1 CANISTER | 2014-08-25 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Epifoam 100 mg/10g; 100 mg/10gthis 00037-6824-10 | Viatris | 1 canister | $10.000 | BX | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 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 8, 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.
-
UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
-
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.
-
UNII BXR49TP611
Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
-
UNII N72LMW566G
A synthetic cleansing agent derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oil and water-based ingredients in liquid medicines, acting as an emulsifier and solubilizer.
-
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.
-
UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
-
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.
-
UNII T75W9911L6
A flammable gas used as a propellant in aerosol formulations. It helps dispense the medicine as a fine mist or spray when you activate the inhaler or pump.
-
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.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
-
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.
12 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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
More NDCs from Viatris Specialty LLC labeler code 00037
- Elestrin Estradiol .52 mg/.87g Gel, Metered NDC 0037-4801-70
- Edluar Zolpidem Tartrate 10 mg Tablet NDC 0037-6010-02
- Edluar Zolpidem Tartrate 5 mg Tablet NDC 0037-6050-30
- Urelle hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate .12 mg; 81 mg; 10.8 mg; 32.4 mg; 40.8 mg Tablet NDC 0037-6321-90
- Proctofoam HC pramoxine hydrochloride hydrocortisone acetate 100 mg/10g; 100 mg/10g Aerosol, Foam NDC 0037-6822-10
- Proctofoam Ns pramoxine hydrochloride 150 mg/15g Aerosol, Foam NDC 0037-6823-15
- Cortifoam hydrocortisone acetate 1500 mg/15g Aerosol, Foam NDC 0037-6830-15
- Dipentum olsalazine sodium 250 mg Capsule, Gelatin Coated NDC 0037-6860-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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 affected area 3 to 4 times daily. 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.
Directions For Use: 1. Shake the container vigorously for 5-10 seconds before each use. 2.
While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to affected area 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to affected areas.
NOTE: The aerosol container should never be inserted into vagina or anus. 3. The container and cap should be disassembled and rinsed with warm water after use.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
⚠️ Warnings ▾
WARNINGS Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 approximately 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, Miliaria
🤰 Pregnancy ▾
Pregnancy 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 of 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 SUSCEPTIBILTY TO TOPICAL CORTICOSTEROID-INDUCED 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 cortisone 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.
🧓 Geriatric Use ▾
Geriatric Use Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS .)
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic 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. Pramoxine Hydrochloride A surface or local anesthetic which is not chemically related to the “caine” types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.
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 disease processes in the skin increase the percutaneous absorption of topical corticosteroids.
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 Epifoam ® is supplied in 10 g pressurized cans. NDC 0037-6824-10 10 g Store upright at controlled room temperature 20° – 25°C (68° – 77°F). DO NOT REFRIGERATE. Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc. For Medical Inquiries, call toll-free 1-877-848-6610 EPIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. IN-682410-05 141341-0224
📋 Description ▾
DESCRIPTION Epifoam ® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane. Epifoam ® contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.
Hydrocortisone acetate Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1mg/100mL. Chemical name: Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-.
Pramoxine hydrochloride Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in water. Chemical name: morpholine, 4-[3-(4- butoxyphenoxy) propyl]-, hydrochloride.
Hydrocortisone Acetate Structural Formula Pramoxine Hydrochloride Structural Formula
⚠️ Precautions ▾
PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.
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 steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
In pediatric patients absorption may result in higher blood levels and thus more susceptibility to systemic toxicity. (See PRECAUTIONS-Pediatric Use .) If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.
If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. 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.
Do not use this medication for any disorder other than for which it has been prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Report any signs of local adverse reactions especially under occlusive dressings. 5.
Do not use any tight fitting diapers or plastic pants on a pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy 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 of 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. Nursing mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when any topical corticosteroids are administered to a nursing woman. Pediatric Use PEDIATRIC PATIENTS MAY DEMONSTRATE GREATER SUSCEPTIBILTY TO TOPICAL CORTICOSTEROID-INDUCED HPA AXIS SUPPRESSION AND CUSHING’S SYNDROME THAN MATURE PATIENTS BECAUSE OF A LA… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when any topical corticosteroids are administered to a nursing woman.
🧬 Pharmacokinetics ▾
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 disease processes in the skin increase the percutaneous absorption of topical corticosteroids.
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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0037-6824-10 epifoam ® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol Rx Only MEDA 10 g net wt Description: A topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, puried water, and inert propellants: isobutane and propane. WARNINGS: Contents of the container are under pressure.
Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Directions for Use See package insert for full prescribing information.
1. Shake the container vigorously for 5-10 seconds before each use. 2.
While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to a‑ected areas 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to a‑ected areas.
NOTE: The aerosol container should never be inserted into vagina or anus. 3. The container and cap should be disassembled and rinsed with warm water after use.
Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. ©2024 Viatris Inc. EPIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris company.
KEEP OUT OF REACH OF CHILDREN. FOR EXTERNAL USE ONLY. Store upright at controlled room temperature 20° - 25°C (68° - 77°F).
DO NOT REFRIGERATE. 117751-0224 UC-682410-04 Epifoam Carton Label