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 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
each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(Present as the free acid and potassium salt)
*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 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 during the last 3 months of 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 (1-800-222-1222) right away.
FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol
call toll free 1-844-912-4012
NDC 37835-588-80
Compare to the active ingredients in ADVIL ®LIQUI-GELS ®*
Ibuprofen Capsules,200 mg
Pain Reliever/Fever Reducer (NSAID)
80 SOFTGELS*
(*Liquid Filled Capsules)
*This product is not manufactured or distributed by the owner of the registered trademark ADVIL ®LIQUI-GELS ®.
Distributed by:
BI-MART
Eugene, OR 97402
NDC 37835-588-16
Compare to the active ingredients in ADVIL ®LIQUI-GELS ®*
Ibuprofen Capsules,200 mg
Pain Reliever/Fever Reducer (NSAID)
160 SOFTGELS*
(*Liquid Filled Capsules)
*This product is not manufactured or distributed by the owner of the registered trademark ADVIL ®LIQUI-GELS ®.
Distributed by:
BI-MART
Eugene, OR 97402
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
|---|---|---|---|---|---|---|
| 37835-588-16 | Ibuprofen | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | 1 | |
| 37835-588-80 | Ibuprofen | 80 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 80 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37835-588 | 37835-588-80, 37835-588-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A078682-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 |
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 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 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 | Bi-Mart | df8aa8bf-720a-483a-b6d9-e4bf8a2d9440 | 2025-03-01 | Warnings | 37835-588-16 37835-588-80 37835-588 37835058816 37835058880 30d4546b-ab1c-bbf8-e063-6394a90a2eec df8aa8bf-720a-483a-b6d9-e4bf8a2d9440 |
Adverse event summaries are temporarily unavailable. Other product information remains available.