Ibuprofen 200mg (Ibuprofen 200mg)

Allegiant Health · tablet · NDC 69168-467

Listed in the FDA National Drug Code directory

Ibuprofen 200mg is an over-the-counter medicine made available by Allegiant Health, on the U.S. market since October 2024. It is marketed under an FDA approval (ANDA ANDA207095), so the FDA has reviewed its safety, effectiveness and manufacturing. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.

What the genuine product looks like

From the official FDA label (version of Sep 30, 2024). Compare the colour, shape, imprint and packaging with what you have. Any difference is a reason to ask a pharmacist before taking it.

Product data on the label: Ibuprofen 200mg Ibuprofen 200mg IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 FERRIC OXIDE RED LECITHIN, SOYBEAN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE BI06

Text on the package panel: Principal Display Panel Ibuprofen Ibuprofen

What it is for

Purpose Pain Reliever/Fever reducer

Key warnings

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing…

Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.

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Recalls of this product

No FDA recalls are recorded for NDC 69168-467. Recalls are listed in FDA enforcement reports from 2004 onward.

Most reported side effects for ibuprofen 200mgReports to the FDA Adverse Event Reporting System (FAERS), all products with this ingredient
Drug ineffective15,939 reports
Pain15,218 reports
Fatigue14,700 reports
Nausea13,731 reports
Headache12,253 reports
Arthralgia11,066 reports
Dyspnoea10,670 reports
Vomiting10,129 reports
Diarrhoea9,841 reports
Rash9,151 reports
Show as table
ItemValue (reports)
Drug ineffective15,939
Pain15,218
Fatigue14,700
Nausea13,731
Headache12,253
Arthralgia11,066
Dyspnoea10,670
Vomiting10,129
Diarrhoea9,841
Rash9,151

These counts are reports, not proof that the medicine caused the problem. Popular medicines get more reports simply because more people take them. They are useful for spotting what to watch for, not for comparing medicines.

Official listing

Brand
Ibuprofen 200mg
Generic name
Ibuprofen 200mg
Company
Allegiant Health
Form
tablet
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2026
Product NDC
69168-467

Active ingredients

Ibuprofen
200 mg/1

Packages (5)

The last part of the NDC identifies the pack size. Your box should show one of these.

69168-467-01 1 bottle in 1 carton (69168-467-01) / 100 tablet in 1 bottle
69168-467-03 250 tablet in 1 bottle (69168-467-03)
69168-467-05 500 tablet in 1 bottle (69168-467-05)
69168-467-30 1 bottle in 1 carton (69168-467-30) / 30 tablet in 1 bottle
69168-467-32 100 tablet in 1 bottle (69168-467-32)

Think your pack is fake?

Stop taking it, keep the pack and receipt, and show it to a pharmacist. In the U.S., report it to FDA MedWatch; elsewhere, to your national medicines regulator. How to spot a fake medicine.

Source: openFDA (U.S. Food and Drug Administration) drug directory, labels, enforcement reports and FAERS, retrieved Nov 9, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.