Indications and uses
• temporarily relieves minor aches and pains due to: o backache o menstrual cramps o toothache o muscular aches o headache o the common cold o minor pain of arthritis • temporarily reduces fever
44-438-DSP
- Manufacturer
- Cardinal Health 107, LLC
- Effective date
- 2026-05-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 17
- Source
- daily-update
- Hydrated at
- 2026-06-03 18:03:25
Label at a glance#
ProductIbuprofen
Active ingredientIBUPROFEN
Label structure10 sections
Dosage and administration
• do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist o if pain or fever does not respond to 1 tablet, 2 tablets may be used o do not exceed 6 tablets in 24 hours, unless directed by a doctor • children under 12 years: ask a doctor
Storage and handling
• store between 20°-25°C (68°-77°F) • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • avoid excessive heat 40°C (104°F) • use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each white tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- backache
- menstrual cramps
- toothache
- muscular aches
- headache
- the common cold
- minor pain of arthritis
- temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- rash
- facial swelling
- shock
- blisters
- skin reddening
- hives
- asthma (wheezing)
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
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have had stomach ulcers or bleeding problems
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
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- stomach bleeding warning applies to you
- 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
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- store between 20°-25°C (68°-77°F)
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- avoid excessive heat 40°C (104°F)
- use by expiration date on package
Inactive ingredients
colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
.
Overbagged with 10 film-coated tablets per bag, NDC 55154-0669-0
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Distributed By:
Cardinal Health
Dublin, OH 43017
L3432333-11024 / L3432333-21024
Rev. 12/25 | M-17 | Re-order No. 301559 |
Principal Display Panel
NDC 55154-0669-0
IBUPROFEN TABLETS, USP 200mg
Pain Reliever/Fever Reducer (NSAID)
10 TABLETS
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0055154066907 | GTIN-13: 0055154066907 EAN-13: 0055154066907 GTIN-12: 055154066907 UPC-A: 055154066907 GTIN storage (14 digits): 00055154066907 | dcd65ab9-888c-4834-a3fa-579fae91c22d-00.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7914-51 | EA - Each | 0904-7914 | faa93b86-ce5e-4cea-a618-d30548170c01 | 1 | 2013-02-11 |
| 0904-7914-59 | EA - Each | 0904-7914 | 6207b3ed-4288-4025-95b9-9f3de378829a | 1 | 2013-02-11 |
| 0904-7914-61 | EA - Each | 0904-7914 | 63c8e5fc-e8e6-4891-8a01-75cb82149419 | 1 | 2013-02-13 |
| 0904-7914-80 | EA - Each | 0904-7914 | 6bc0c001-c7a4-41d8-a354-be1952047e0a | 1 | 2018-05-09 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 5 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 5 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 5 |
Products#
Every source-derived product name is available through these pages.
- Ibuprofen
- SILICON DIOXIDE
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- ANHYDROUS LACTOSE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55154-0669 | 55154-0669-0 |
| 0904-7914 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 16 | 2026-01-22 | full-release | 2026-06-01 01:34:52 |
| 15 | 2025-10-15 | monthly-update | 2026-06-03 17:39:43 |
| 14 | 2024-10-22 | full-release | 2026-06-01 00:29:05 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075139-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Cardinal Health 107, LLC | 260f5862-d65d-4c34-bf53-26ca30806a67 | 2026-05-19 | Warnings | 55154-0669-0 55154-0669 55154066900 1f066e05-cece-4b1c-a98f-3e756065bdc8 260f5862-d65d-4c34-bf53-26ca30806a67 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.