CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Ibuprofen Oral (Ibuprofen Oral)
Strategic Sourcing Services · suspension · NDC 70677-0150
Listed in the FDA National Drug Code directory
Ibuprofen Oral is an over-the-counter medicine made available by Strategic Sourcing Services, on the U.S. market since November 2018. It is marketed under an FDA approval (ANDA ANDA210602), 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 Aug 10, 2022). 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 Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM D&C YELLOW NO. 10 GLYCERIN FD&C RED NO. 40 CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM IBUPROFEN IBUPROFEN Ibuprofen Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM IBUPROFEN IBUPROF…
Text on the package panel: PRINCIPAL DISPLAY PANEL Ibuprofen oral suspension berry flavour with dye container carton Ibuprofen oral suspension berry flavour with dye free container carton Ibuprofen oral suspension grape flavour container carton Ibuprofen oral suspension bubble gum flavour container carton berry-4oz berry-dye-free grape bubble-gum
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 an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, …
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 70677-0150. Recalls are listed in FDA enforcement reports from 2004 onward.
Other recent recalls of ibuprofen oral
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
Drug ineffective15,933 reports
Pain15,215 reports
Fatigue14,693 reports
Nausea13,725 reports
Headache12,242 reports
Arthralgia11,064 reports
Dyspnoea10,663 reports
Vomiting10,122 reports
Diarrhoea9,834 reports
Rash9,144 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 15,933 |
| Pain | 15,215 |
| Fatigue | 14,693 |
| Nausea | 13,725 |
| Headache | 12,242 |
| Arthralgia | 11,064 |
| Dyspnoea | 10,663 |
| Vomiting | 10,122 |
| Diarrhoea | 9,834 |
| Rash | 9,144 |
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 Oral
Generic name
Ibuprofen Oral
Company
Strategic Sourcing Services
Form
suspension
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
70677-0150
Active ingredients
Ibuprofen
100 mg/5mL
Packages (2)
The last part of the NDC identifies the pack size. Your box should show one of these.
70677-0150-1 1 bottle in 1 carton (70677-0150-1) / 118 ml in 1 bottle
70677-0150-2 1 bottle in 1 carton (70677-0150-2) / 237 ml in 1 bottle
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.