Clobetasol Propionate .4625 mg/mL Solution — NDC 33342-321-86 (Billing 33342-0321-86)
This is a package of Clobetasol Propionate .4625 mg/mL Solution from Macleods Pharmaceuticals Limited, marketed since Nov 2017 and currently FDA-listed; retail pharmacies pay about $0.1359 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
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): 015349
- GCN: 15891
- GPI-14 (Medi-Span): 90550025102005
- HICL (First Databank): 003327
- AHFS class code: 84:06.08.00
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
Clinical
- It calms inflamed, itchy skin and scalp conditions, including plaque psoriasis. The exact use depends on your product, such as shampoo for scalp psoriasis or spray for plaque psori...
- Usually only a short time, often 2 weeks and up to 4 weeks for some products. Stop when your skin is under control. If you see no improvement in 2 weeks, check back with your presc...
- Generally no. Most clobetasol skin products should not be used on the face, armpits or groin. Keep it out of your eyes and mouth, and follow your product's directions.
- Mild burning, stinging, itching or dryness where you apply it. Call your doctor if your skin thins, breaks out, looks infected or gets worse. Also call for signs of steroid effects...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.136 | $6.80 / 50 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.4021 | $20.11 / 50 ml |
| 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 Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 |
|---|---|---|---|---|---|---|
| 33342-0321-39 33342-321-39 | 1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE | — | — | 2021-10-08 | — | Active |
| 33342-0321-86 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE | $0.1359 / mL | $6.80 | 2017-11-04 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Clobetasol Propionate .4625 mg/mL Solution?
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 |
|---|---|---|---|---|---|---|
| clobetasol propionate .5 mg/mL 43386-0028-60 | Lupin | 1 bottle | $0.120 | AT | FDA listed | save 11% |
| Clobetasol Propionate .5 mg/mL 00168-0269-50 | E. | 50 ml | $0.136 | AT | Availability likely | — |
| Clobetasol Propionate .4625 mg/mLthis 33342-0321-86 | Macleods | 1 bottle | $0.136 | AT | Availability likely | — |
| Clobetasol Propionate .5 mg/mL 70752-0153-04 | Quagen | 1 bottle | $0.136 | AT | Availability likely | — |
| Clobetasol Propionate .5 mg/mL 21922-0061-22 | Encube | 1 bottle | $0.240 | AT | Availability likely | +77% |
| Clobetasol Propionate .5 mg/mL 42571-0362-81 | Micro | 1 bottle | $0.240 | AT | Availability likely | +77% |
| Clobetasol Propionate .5 mg/mL 51672-1293-02 | Sun | 1 bottle | $0.240 | AT | Availability likely | +77% |
| Clobetasol Propionate .5 mg/mL 62332-0486-25 | Alembic | 1 bottle | $0.240 | AT | Availability likely | +77% |
| Clobetasol Propionate .5 mg/mL 68462-0532-28 | Glenmark | 1 bottle | $0.362 | — | FDA listed | +166% |
| clobetasol propionate .5 mg/mL 40032-0028-60 | Novel | 1 bottle | — | AT | FDA listed | — |
| Clobetasol Propionate .5 mg/mL 46708-0486-25 | Alembic | 1 bottle | — | AT | FDA listed | — |
| Clobetasol Propionate .5 mg/mL 50090-5264-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Clobetasol Propionate .5 mg/mL 51407-0737-25 | Golden | 1 bottle | — | AT | FDA listed | — |
| Clobetasol Propionate .4625 mg/mL 50090-5778-00 | A-S | 1 bottle | — | AT | FDA listed | — |
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
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 ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
4 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 & USAGE Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night. Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used. Clobetasol propionate topical solution is not to be used with occlusive dressings.
Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clobetasol propionate topical solution is generally well tolerated when used for 2-week treatment periods. The most frequent adverse events reported for clobetasol propionate topical solution have been local and have included burning and/ or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. 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, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients.
In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended. To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
PREGNANCY Teratogenic Effects 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 to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate topical solution.
Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate topical solution.
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol propionate topical solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
PEDIATRIC USE Use of clobetasol propionate topical solution in pediatric patients under 12 years of age is not recommended. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing 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 A limited number of patients at or above 65 years of age (n = 65) have been treated with clobetasol propionate topical solution in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of clobetasol propionate topical solution in geriatric patients is warranted.
🆘 Overdosage ▾
OVERDOSAGE Topically applied clobetasol propionate topical solution can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions.
However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ).
As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly 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, including clobetasol propionate and its metabolites, are also excreted into the bile. Following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that clobetasol propionate topical solution has the potential to depress plasma cortisol levels in some patients. However, hypothalamic-pituitary-adrenal (HPA) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a 2-week course of treatment.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clobetasol Propionate Topical Solution, USP, 0.05% w/w is supplied in plastic squeeze bottles, 25 mL (NDC 33342-321-39) 50 mL (NDC 33342-321-86) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not use near an open flame. Rx only Manufactured for : Macleods Pharma USA, Inc.
Princeton, NJ 08540 Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Revision: December 2022
📋 Description ▾
DESCRIPTION Clobetasol Propionate Topical Solution, USP, 0.05% w/w contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 32 ClFO 5 and a molecular weight of 467.
It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide. str
💬 Information for Patients ▾
INFORMATION FOR PATIENTS Patients using clobetasol propionate topical solution should receive the following information and instructions: 1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only.
Avoid contact with the eyes. 2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. 4.
Patients should report any signs of local adverse reactions to the physician.
⚠️ Precautions ▾
PRECAUTIONS GENERAL PRECAUTION Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g (of ointment) per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients. Conditions that augment systemic absorption include the application of the more potent corticosteroids, 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 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. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
Irritation is possible if clobetasol propionate topical solution contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended. If the inflammatory lesion becomes infected, 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. Although clobetasol propionate topical solution is intended for the treatment of inflammatory conditions of the scalp, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.
As with other potent topical corticosteroids, clobetasol propionate topical solution should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis. INFORMATION FOR PATIENTS Patients using clobetasol propionate topical solution should receive the following information and instructions: 1.
This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it was prescribed. 3.
The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. 4. Patients should report any signs of local adverse reactions to the physician.
LABORATORY TESTS The following tests may be helpful in evaluating patients for HPA axis suppression: Urinary free cortisol test ACTH stimulation test CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. PREGNANCY Teratogenic Effects Corticosteroids have been shown to be teratogeni… [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 clobetasol propionate topical solution is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL R x Only NDC 33342-321-86 Clobetasol Propionate Topical Solution, USP 0.05 % w/w 50 mL Bottle Principal Display Panel Bottle Side Display Panel Carton Label R x Only NDC 33342-321-39 Clobetasol Propionate Topical Solution, USP 0.05 % w/w 25 mL Bottle Principal Display Panel Bottle Side Display Panel Carton Label bottle-front bottle-rear clobetasol-carton.jpg bottle-front-25-ml.jpg bottle-rear-25-ml.jpg clobetasol-carton-25-ml.jpg