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Brand-name prescription medicine

Combogesic

Generic name: Acetaminophen and ibuprofen

FDA application holder: Aft Pharms US

Strengths and generic versions Official label

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. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

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

At a glance

1Strengths and forms
0Same medicine, other names
2023FDA approval
0Recalls (FDA reports)

Quick answers

What is Combogesic?
Combogesic is a brand name of Acetaminophen and ibuprofen, a prescription medicine. The FDA NDC Directory lists 4 Combogesic products in 1 strength and form.
Who makes Combogesic?
Aft Pharms US holds the FDA application for Combogesic (NDA209471, approved March 1, 2023). 2 other companies (repackagers or distributors) also list Combogesic products.
Is there a generic or store brand of Combogesic?
Other products of Acetaminophen and ibuprofen are listed with the FDA, but none in exactly the same strength and form as a Combogesic product.
Has Combogesic been recalled?
No recall linked to Combogesic products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Combogesic is

Each Combogesic 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.

Acetaminophen and ibuprofen · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 325 mg · ibuprofen 97.5 mg
tablet, film coated (oral)		 Combogesic None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Acetaminophen and ibuprofen →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Combogesic products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA209471Aft Pharms USMarch 1, 20234

Companies that list Combogesic

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

Recalls

No recall linked to Combogesic 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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