Quick answers
- What is Nizoral?
- Nizoral is a brand name of Ketoconazole and Hydrocortisone, an over-the-counter medicine. The FDA NDC Directory lists 4 Nizoral products in 3 strengths and forms.
- Who makes Nizoral?
- Kramer holds the FDA application for Nizoral (NDA020310, approved October 10, 1997).
- Is there a generic or store brand of Nizoral?
- Yes. The FDA NDC Directory lists 9 other products with the same active ingredients, strength and form as a Nizoral product, 9 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Nizoral been recalled?
- No recall linked to Nizoral products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Nizoral is
Each Nizoral product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ketoconazole · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ketoconazole 1% shampoo (topical) | Nizoral | 7 products, 3 companies | — |
| ketoconazole 10 mg/mL shampoo (topical) | Nizoral | 1 product, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Ketoconazole →
Hydrocortisone · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| hydrocortisone 10 mg/mL shampoo (topical) | Nizoral Scalp Itch Relief | 1 product, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Hydrocortisone →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020310 | Kramer | October 10, 1997 | 3 |
Companies that list Nizoral
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nizoral products.
- Kramer Laboratories4 products
Recalls
No recall linked to Nizoral products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.