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Brand-name over-the-counter medicine

Imodium

Generic names: Loperamide · Dimethicone and loperamide hydrochloride

FDA application holder: Kenvue Brands

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Read the label on your package, and ask a pharmacist if you are not sure a medicine is right for you or your child.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Imodium?
Imodium is a brand name of Loperamide and Dimethicone and loperamide hydrochloride, an over-the-counter medicine. The FDA NDC Directory lists 3 Imodium products in 3 strengths and forms.
Who makes Imodium?
Kenvue Brands holds the FDA application for Imodium (NDA019487, approved March 1, 1988).
Is there a generic or store brand of Imodium?
Yes. The FDA NDC Directory lists 96 other products with the same active ingredients, strength and form as a Imodium product, 70 of them generic or store brands. Ask your pharmacist whether one is right for you.
Has Imodium been recalled?
No recall linked to Imodium products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Imodium is

Each Imodium 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.

Loperamide · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
loperamide hydrochloride 1 mg/7.5 mL
solution (oral)
Imodium A-D 26 products, 22 companies DailyMed
loperamide hydrochloride 2 mg
capsule, liquid filled (oral)
Imodium A-D 31 products, 27 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Loperamide →

Dimethicone and loperamide hydrochloride · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
dimethicone 125 mg · loperamide hydrochloride 2 mg
tablet (oral)
IMODIUM Multi-Symptom Relief 39 products, 33 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Dimethicone and loperamide hydrochloride →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Imodium products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA019487Kenvue BrandsMarch 1, 19881
NDA021140Kenvue BrandsNovember 30, 20001
NDA021855BionpharmaAugust 4, 20051

Companies that list Imodium

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Imodium products.

  • Kenvue Brands LLC3 products

Recalls

No recall linked to Imodium products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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