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Ibuprofen
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Ibuprofen | 200 mg/1 | 310965 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 207753-001 | IBUPROFEN | CAPSULE | IBUPROFEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | June 29, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260605). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches the common cold minor pain of arthritis temporarily reduces fever
Purpose
openFDA Drug LabelingPurpose Pain reliever/Fever reducer
Dosage and Administration
openFDA Drug LabelingDirections do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 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 prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do Not Use
openFDA Drug LabelingDo not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear. If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 59651-072-82 | 59651-072 | Aurobindo Pharma Limited | 800 CAPSULE in 1 BAG (59651-072-82) | June 29, 2018 |
| 59651-627-39 | 59651-627 | Aurobindo Pharma Limited | 3000 CAPSULE in 1 BAG (59651-627-39) | April 15, 2021 |
| 59651-627-82 | 59651-627 | Aurobindo Pharma Limited | 800 CAPSULE in 1 BAG (59651-627-82) | April 2, 2019 |
| 58602-843-12 | 58602-843 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-843-12) / 40 CAPSULE in 1 BOTTLE | July 15, 2020 |
| 58602-843-18 | 58602-843 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-843-18) / 80 CAPSULE in 1 BOTTLE | July 15, 2020 |
| 58602-843-30 | 58602-843 | Aurohealth LLC | 160 CAPSULE in 1 BOTTLE (58602-843-30) | July 15, 2020 |
| 58602-843-32 | 58602-843 | Aurohealth LLC | 180 CAPSULE in 1 BOTTLE (58602-843-32) | July 15, 2020 |
| 58602-843-34 | 58602-843 | Aurohealth LLC | 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-34) | August 27, 2020 |
| 58602-843-38 | 58602-843 | Aurohealth LLC | 300 CAPSULE in 1 BOTTLE (58602-843-38) | July 15, 2020 |
| 58602-843-70 | 58602-843 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC | August 27, 2020 |
| 58602-843-72 | 58602-843 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC | August 27, 2020 |
| 58602-843-73 | 58602-843 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-843-73) / 20 CAPSULE in 1 BOTTLE | July 15, 2020 |
| 58602-843-74 | 58602-843 | Aurohealth LLC | 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-74) | August 27, 2020 |
| 58602-843-75 | 58602-843 | Aurohealth LLC | 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-75) | August 27, 2020 |
| 58602-843-79 | 58602-843 | Aurohealth LLC | 2 BOTTLE in 1 CARTON (58602-843-79) / 180 CAPSULE in 1 BOTTLE | July 15, 2020 |
| 58602-843-92 | 58602-843 | Aurohealth LLC | 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-92) | August 27, 2020 |
| 58602-852-32 | 58602-852 | Aurohealth LLC | 180 CAPSULE in 1 BOTTLE (58602-852-32) | July 18, 2022 |
| 58602-852-38 | 58602-852 | Aurohealth LLC | 300 CAPSULE in 1 BOTTLE (58602-852-38) | July 18, 2022 |
| 58602-879-38 | 58602-879 | Aurohealth LLC | 300 CAPSULE in 1 BOTTLE (58602-879-38) | September 6, 2022 |
| 58602-902-12 | 58602-902 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-902-12) / 40 CAPSULE in 1 BOTTLE | June 29, 2018 |
| 58602-902-18 | 58602-902 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-902-18) / 80 CAPSULE in 1 BOTTLE | June 29, 2018 |
| 58602-902-30 | 58602-902 | Aurohealth LLC | 160 CAPSULE in 1 BOTTLE (58602-902-30) | June 29, 2018 |
| 58602-902-32 | 58602-902 | Aurohealth LLC | 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-32) | March 31, 2020 |
| 58602-902-34 | 58602-902 | Aurohealth LLC | 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-34) | March 31, 2020 |
| 58602-902-38 | 58602-902 | Aurohealth LLC | 300 CAPSULE in 1 BOTTLE (58602-902-38) | June 29, 2018 |
| 58602-902-70 | 58602-902 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-902-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC | March 31, 2020 |
| 58602-902-72 | 58602-902 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-902-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC | March 31, 2020 |
| 58602-902-73 | 58602-902 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-902-73) / 20 CAPSULE in 1 BOTTLE | June 29, 2018 |
| 58602-902-74 | 58602-902 | Aurohealth LLC | 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-74) | March 31, 2020 |
| 58602-902-75 | 58602-902 | Aurohealth LLC | 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-75) | March 31, 2020 |
| 21130-032-12 | 21130-032 | Better Living Brands LLC | 1 BOTTLE in 1 CARTON (21130-032-12) / 40 CAPSULE in 1 BOTTLE | September 20, 2023 |
| 21130-032-18 | 21130-032 | Better Living Brands LLC | 1 BOTTLE in 1 CARTON (21130-032-18) / 80 CAPSULE in 1 BOTTLE | September 20, 2023 |
| 21130-032-32 | 21130-032 | Better Living Brands LLC | 180 CAPSULE in 1 BOTTLE (21130-032-32) | September 20, 2023 |
| 21130-032-38 | 21130-032 | Better Living Brands LLC | 300 CAPSULE in 1 BOTTLE (21130-032-38) | September 20, 2023 |
| 49588-0005-1 | 49588-0005 | CATALENT ARGENTINA S.A.I.C. | 1 BAG in 1 BOX (49588-0005-1) / 15000 CAPSULE in 1 BAG | June 27, 2025 |
| 11014-0429-2 | 11014-0429 | Catalent Pharma Solutions, LLC | 1 BAG in 1 CARTON (11014-0429-2) / 6000 CAPSULE in 1 BAG | March 19, 2014 |
| 10888-8114-1 | 10888-8114 | Patheon Softgels Inc. | 10000 CAPSULE in 1 BOX (10888-8114-1) | December 5, 2017 |
| 10888-8118-1 | 10888-8118 | Patheon Softgels Inc. | 6000 CAPSULE in 1 BOX (10888-8118-1) | January 1, 2018 |
| 10888-8133-1 | 10888-8133 | Patheon Softgels Inc. | 6000 CAPSULE in 1 BOX (10888-8133-1) | August 1, 2014 |
| 10888-8134-1 | 10888-8134 | Patheon Softgels Inc. | 6000 CAPSULE in 1 BOX (10888-8134-1) | January 7, 2014 |
| 10888-8135-1 | 10888-8135 | Patheon Softgels Inc. | 10000 CAPSULE in 1 BOX (10888-8135-1) | June 2, 2010 |
| 10888-8160-1 | 10888-8160 | Patheon Softgels Inc. | 6000 CAPSULE in 1 CASE (10888-8160-1) | January 28, 2019 |
| 10888-8161-1 | 10888-8161 | Patheon Softgels Inc. | 15000 CAPSULE in 1 CASE (10888-8161-1) | May 4, 2020 |
| 10888-8170-1 | 10888-8170 | Patheon Softgels Inc. | 10000 CAPSULE in 1 CASE (10888-8170-1) | May 10, 2018 |
| 10888-8231-1 | 10888-8231 | Patheon Softgels Inc. | 15000 CAPSULE in 1 CASE (10888-8231-1) | April 30, 2021 |
| 10888-8266-1 | 10888-8266 | Patheon Softgels, Inc. | 15000 CAPSULE in 1 BOX (10888-8266-1) | May 28, 2025 |
| 11822-4258-1 | 11822-4258 | RITE AID CORPORATION | 1 BOTTLE in 1 CARTON (11822-4258-1) / 20 CAPSULE in 1 BOTTLE | June 24, 2022 |
| 11822-4258-2 | 11822-4258 | RITE AID CORPORATION | 1 BOTTLE in 1 CARTON (11822-4258-2) / 40 CAPSULE in 1 BOTTLE | June 24, 2022 |
| 11822-4258-3 | 11822-4258 | RITE AID CORPORATION | 1 BOTTLE in 1 CARTON (11822-4258-3) / 80 CAPSULE in 1 BOTTLE | June 24, 2022 |
| 11822-4258-4 | 11822-4258 | RITE AID CORPORATION | 160 CAPSULE in 1 BOTTLE (11822-4258-4) | June 24, 2022 |
| 11822-4258-5 | 11822-4258 | RITE AID CORPORATION | 300 CAPSULE in 1 BOTTLE (11822-4258-5) | June 24, 2022 |
| 11822-4258-6 | 11822-4258 | RITE AID CORPORATION | 200 CAPSULE in 1 BOTTLE, PLASTIC (11822-4258-6) | April 12, 2023 |
| 59651-072 | 59651-072 | Aurobindo Pharma Limited | — | June 29, 2018 |
| 59651-627 | 59651-627 | Aurobindo Pharma Limited | — | April 2, 2019 |
| 58602-843 | 58602-843 | Aurohealth LLC | — | July 15, 2020 |
| 58602-852 | 58602-852 | Aurohealth LLC | — | July 18, 2022 |
| 58602-879 | 58602-879 | Aurohealth LLC | — | September 6, 2022 |
| 58602-902 | 58602-902 | Aurohealth LLC | — | June 29, 2018 |
| 21130-032 | 21130-032 | Better Living Brands LLC | — | September 20, 2023 |
| 49588-0005 | 49588-0005 | CATALENT ARGENTINA S.A.I.C. | — | June 27, 2025 |
| 11014-0429 | 11014-0429 | Catalent Pharma Solutions, LLC | — | March 19, 2014 |
| 10888-8114 | 10888-8114 | Patheon Softgels Inc. | — | March 24, 2009 |
| 10888-8118 | 10888-8118 | Patheon Softgels Inc. | — | March 24, 2009 |
| 10888-8133 | 10888-8133 | Patheon Softgels Inc. | — | March 24, 2009 |
| 10888-8134 | 10888-8134 | Patheon Softgels Inc. | — | March 24, 2009 |
| 10888-8135 | 10888-8135 | Patheon Softgels Inc. | — | March 24, 2009 |
| 10888-8160 | 10888-8160 | Patheon Softgels Inc. | — | January 28, 2019 |
| 10888-8161 | 10888-8161 | Patheon Softgels Inc. | — | May 4, 2020 |
| 10888-8170 | 10888-8170 | Patheon Softgels Inc. | — | May 10, 2018 |
| 10888-8231 | 10888-8231 | Patheon Softgels Inc. | — | April 30, 2021 |
| 10888-8266 | 10888-8266 | Patheon Softgels, Inc. | — | May 28, 2025 |
| 11822-4258 | 11822-4258 | RITE AID CORPORATION | — | June 24, 2022 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.