Quick answers
- What is Plan B One?
- Plan B One is a brand name of Levonorgestrel, an over-the-counter medicine. The FDA NDC Directory lists 3 Plan B One products in 1 strength and form.
- Who makes Plan B One?
- FDN Consumer holds the FDA application for Plan B One (NDA021998, approved July 10, 2009). 1 other company (repackagers or distributors) also list Plan B One products.
- Is there a generic or store brand of Plan B One?
- Yes. The FDA NDC Directory lists 50 other products with the same active ingredients, strength and form as a Plan B One product, 50 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Plan B One been recalled?
- No recall linked to Plan B One products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Plan B One is
Each Plan B One 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.
Levonorgestrel · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| levonorgestrel 1.5 mg tablet (oral) | Plan B One-Step | 50 products, 27 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Levonorgestrel →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021998 | FDN Consumer | July 10, 2009 | 3 |
Companies that list Plan B One
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Plan B One products.
- Foundation Consumer Healthcare LLC2 products
- A-S Medication Solutions1 product
Recalls
No recall linked to Plan B One 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.