Quick answers
- What is Betamethasone dipropionate used for?
- The FDA-approved label (Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, August 21, 2026) says: “Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Betamethasone dipropionate?
- The “Adverse Reactions” section of the FDA label (Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, August 21, 2026) begins: “The following local adverse reactions are reported infrequently when Betamethasone Dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Betamethasone dipropionate have a boxed warning?
- No. None of the 55 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Betamethasone dipropionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Betamethasone dipropionate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Betamethasone dipropionate?
- 26 companies list prescription products of Betamethasone dipropionate in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Sun Pharmaceutical Industries, Inc.
What Betamethasone dipropionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
— FDA label: Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (cream, topical), Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 55 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 55 FDA labels for this medicine have a boxed warning.
Betamethasone dipropionate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following local adverse reactions are reported infrequently when Betamethasone Dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section.
Read more of this section
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 infections, skin atrophy, striae and miliaria. 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.
— FDA label: Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026. Read the full label on DailyMed →
Betamethasone dipropionate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Apply a thin film of Betamethasone Dipropionate Cream or Ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary. Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night. If an infection develops, appropriate antimicrobial therapy should be instituted.
Read more of this section
Betamethasone Dipropionate products should not be used with occlusive dressings.
— FDA label: Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026. Read the full label on DailyMed →
Betamethasone dipropionate and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
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. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
— FDA label: Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026. Read the full label on DailyMed →
When Betamethasone dipropionate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
— FDA label: Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026. Read the full label on DailyMed →
Betamethasone dipropionate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
— FDA label: Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026. Read the full label on DailyMed →
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| betamethasone dipropionate 0.05% cream | Generic | $0.1237–$0.4641 per gram 14 packages, lowest to highest |
| betamethasone dipropionate 0.05% cream, augmented | Generic | $0.1237–$0.2008 per gram 2 packages, lowest to highest |
| betamethasone dipropionate 0.05% gel | Generic | $2.09–$2.85 per gram 2 packages, lowest to highest |
| betamethasone dipropionate 0.05% lotion | Generic | $0.3012 per mL |
| betamethasone dipropionate 0.05% ointment | Generic | $0.3487–$0.4196 per gram 10 packages, lowest to highest |
| betamethasone dipropionate 0.05% ointment, augmented | Generic | $0.5424–$1.43 per gram 8 packages, lowest to highest |
| betamethasone dipropionate 0.5 mg/mL lotion | Generic | $0.3012 per mL |
| betamethasone dipropionate 0.5 mg/mL lotion, augmented | Generic | $0.4916–$0.5487 per mL 6 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions9 products
- Bryant Ranch Prepack7 products
- Sun Pharmaceutical Industries, Inc.5 products
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC5 products
- Padagis Israel Pharmaceuticals Ltd3 products
- Actavis Pharma, Inc.3 products
- Zydus Lifesciences Limited2 products
- Cosette Pharmaceuticals, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Aurobindo Pharma Limited2 products
- NuCare Pharmaceuticals, Inc.2 products
- Lupin Pharmaceuticals, Inc.1 product
- Organon LLC1 product
- Encube Ethicals, Inc.1 product
- Primus Pharmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Viona Pharmaceuticals Inc1 product
- Golden State Medical Supply, Inc.1 product
- TruPharma, LLC1 product
- Prasco Laboratories1 product
- NorthStar Rx LLC1 product
- Burel Pharmaceuticals, LLC1 product
- Asclemed USA, Inc.1 product
- Redpharm Drug1 product
- Proficient Rx LP1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018741 DIPROLENE | Organon | July 27, 1983 | 22, latest May 1, 2019 2019: Labeling · 2018: Labeling · 2014: Labeling |
| NDA019137 BETAMETHASONE DIPROPIONATE | Fougera | June 26, 1984 | 11, latest September 4, 2014 2014: Manufacturing (CMC) · 1997: Manufacturing (CMC) · 1996: Manufacturing (CMC) |
| NDA019141 BETAMETHASONE DIPROPIONATE | Fougera | September 4, 1984 | 12, latest June 7, 1996 1996: Manufacturing (CMC) · 1996: Manufacturing (CMC) · 1995: Labeling |
| NDA208079 SERNIVO | Primus Pharms | February 5, 2016 | 3, latest September 26, 2025 2025: Manufacturing (CMC) · 2020: Labeling · 2018: Labeling |
Generic approvals (23)
- ANDA070275Fougera Pharms Inc · August 12, 1985
- ANDA070885Actavis Mid Atlantic · February 3, 1987
- ANDA071012Actavis Mid Atlantic · February 3, 1987
- ANDA071467Cosette Pharms Nc · August 10, 1987
- ANDA072538Padagis Us · January 31, 1990
- ANDA073552Sun Pharma Canada · April 30, 1992
- ANDA074304Actavis Mid Atlantic · August 31, 1995
- ANDA075373Fougera Pharms · June 22, 1999
- ANDA076508Sun Pharma Canada · December 2, 2003
- ANDA076543Sun Pharma Canada · December 9, 2003
- ANDA076592Padagis Israel · December 9, 2003
- ANDA077111Fougera Pharms · May 21, 2007
- ANDA077477Sun Pharma Canada · May 21, 2007
- ANDA206389Encube · February 13, 2018
- ANDA210217Cosette Pharms Nc · October 12, 2018
- ANDA208885Zydus Pharms · January 11, 2019
- ANDA209106Lupin · December 18, 2019
- ANDA211722Sun Pharma Canada · June 17, 2020
- ANDA214048Zydus Lifesciences · July 14, 2020
- ANDA215186Tp Anda Holdings · February 18, 2022
- ANDA215847Padagis Israel · April 12, 2022
- ANDA218289Aurobindo Pharma Ltd · April 10, 2024
- ANDA219348Aurobindo Pharma Ltd · January 26, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1028-2022
cGMP deviations: Temperature abuse
Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- DiproleneBrand page: products, maker and price
- SernivoBrand page: products, maker and price
- A-S Medication SolutionsMaker or distributor
- Bryant Ranch PrepackMaker or distributor
- Sun Pharmaceutical Industries, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Betamethasone Dipropionate, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective August 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →