Indications and uses
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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
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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Quality
+Plus
NDC 50844-353-16
†Compare to active ingredient
in Motrin® IB Caplets
IBUPROFEN
TABLETS
USP, 200 mg
PAIN RELIEVER/FEVER REDUCER
(NSAID)
1000 Coated Caplets**
(**CAPSULE-SHAPED TABLETS)
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Motrin® IB
Caplets. 50844 REV1221C35316
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0050844353169 | GTIN-13: 0050844353169 EAN-13: 0050844353169 GTIN-12: 050844353169 UPC-A: 050844353169 GTIN storage (14 digits): 00050844353169 | quality-plus-44-353-1.jpg |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50844-353-02 | Ibuprofen | 12 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 12 | 13 | |
| 50844-353-02 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 13 | |
| 50844-353-16 | Ibuprofen | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | 13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| Hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Lactose | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| Polyethylene Glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Povidone | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50844-353 | 50844-353-02, 50844-353-16 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| Hypromellose | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| Lactose | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| Polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| Polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| 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 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | f41ea6bd6efb… |
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 | L.N.K. International, Inc. | c93da67f-f42e-4baa-976b-73c71ba6dd71 | 2026-01-12 | Warnings | 50844-353-16 50844-353-02 50844-353 50844035316 50844035302 5f8c5841-a57f-4394-bbc2-93fc48474282 c93da67f-f42e-4baa-976b-73c71ba6dd71 |
Adverse event summaries are temporarily unavailable. Other product information remains available.