Ibuprofen
- Product NDC
- 11822-4258
- 11-digit product format
- 118224258
- Labeler code
- 11822
- Product ID
- 11822-4258_cf674005-a266-40ec-86eb-8195d1f3ebce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RITE AID CORPORATION
- Application
- ANDA207753
- Marketing category
- ANDA
- Marketing start
- 2022-06-24
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207753-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WK2XYI10QM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310964 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| de158883-1175-18fc-e053-2995a90a3c96 | Available on FDA.report |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-4258-1 | Ibuprofen | 20 in 1 BOTTLE | CAPSULE | 20 | 3 | |
| 11822-4258-1 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 11822-4258-2 | Ibuprofen | 40 in 1 BOTTLE | CAPSULE | 40 | 3 | |
| 11822-4258-2 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 11822-4258-3 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 11822-4258-3 | Ibuprofen | 80 in 1 BOTTLE | CAPSULE | 80 | 3 | |
| 11822-4258-4 | Ibuprofen | 160 in 1 BOTTLE | CAPSULE | 160 | 3 | |
| 11822-4258-5 | Ibuprofen | 300 in 1 BOTTLE | CAPSULE | 300 | 3 | |
| 11822-4258-6 | Ibuprofen | 200 in 1 BOTTLE, PLASTIC | CAPSULE | 200 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-4258 | IBUPROFEN CAPSULE [RITE AID CORPORATION] | 3 | Current NDC, Legacy NDC, 9 package rows | 20230507_de158883-1175-18fc-e053-2995a90a3c96.zip |
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 | Aurohealth LLC | 43c94480-78d1-4a23-91d4-1d49fea72cb7 | 2026-06-05 | Warnings | 207753 ANDA207753 |
| Ibuprofen | IBUPROFEN | P & L Development, LLC | ce215099-91b0-43fd-8ac9-17fe6508842c | 2025-11-11 | Warnings | 207753 ANDA207753 |
| Ibuprofen | IBUPROFEN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | da9d0301-ec14-40c5-b0b9-17096913a849 | 2025-11-11 | Warnings | 207753 ANDA207753 |
| Ibuprofen | IBUPROFEN | Better Living Brands LLC | f6ef7f73-b5ab-4c82-e053-6394a90ac81e | 2023-09-22 | Warnings | 207753 ANDA207753 |
| Ibuprofen | IBUPROFEN | RITE AID CORPORATION | de158883-1175-18fc-e053-2995a90a3c96 | 2023-04-12 | Warnings | 207753 ANDA207753 11822-4258 |
| Ibuprofen | IBUPROFEN | Aurohealth LLC | e1b49257-d226-457f-8f2d-9a757a65bbcb | 2022-09-06 | Warnings | 207753 ANDA207753 |
| Ibuprofen | IBUPROFEN | Aurohealth LLC | 7779c369-50bf-4cde-9015-ff3fb35e128e | 2022-05-16 | Warnings | 207753 ANDA207753 |
| Ibuprofen | IBUPROFEN | Aurohealth LLC | 3b0e77a1-b49d-4c67-81dd-66450dabcf3b | 2022-03-04 | Warnings | 207753 ANDA207753 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310964 | ibuprofen 200 MG Oral Capsule | PSN | de158883-1175-18fc-e053-2995a90a3c96 | 3 |
| 310964 | ibuprofen 200 MG Oral Capsule | SCD | de158883-1175-18fc-e053-2995a90a3c96 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-4258-1 | 11822425801 | 1 BOTTLE in 1 CARTON (11822-4258-1) / 20 CAPSULE in 1 BOTTLE | 1 bottle | 2022-06-24 | 0000-00-00 | No | No | Current |
| 11822-4258-2 | 11822425802 | 1 BOTTLE in 1 CARTON (11822-4258-2) / 40 CAPSULE in 1 BOTTLE | 1 bottle | 2022-06-24 | 0000-00-00 | No | No | Current |
| 11822-4258-3 | 11822425803 | 1 BOTTLE in 1 CARTON (11822-4258-3) / 80 CAPSULE in 1 BOTTLE | 1 bottle | 2022-06-24 | 0000-00-00 | No | No | Current |
| 11822-4258-4 | 11822425804 | 160 CAPSULE in 1 BOTTLE (11822-4258-4) | 160 capsule | 2022-06-24 | 0000-00-00 | No | No | Current |
| 11822-4258-5 | 11822425805 | 300 CAPSULE in 1 BOTTLE (11822-4258-5) | 300 capsule | 2022-06-24 | 0000-00-00 | No | No | Current |
| 11822-4258-6 | 11822425806 | 200 CAPSULE in 1 BOTTLE, PLASTIC (11822-4258-6) | 200 capsule | 2023-04-12 | No | No | Current |