Application 079113
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | TABLET;ORAL | 38MG;200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET / ORAL | 2008-12-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2008-12-22 | f41ea6bd6efb… |
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 pm | DIPHENHYDRAMINE CITRATE, IBUPROFEN | Publix Super Markets Inc | 0240bec9-9477-4d58-9a19-63bb5d2795e0 | 2023-11-13 | Warnings | 079113 ANDA079113 56062-050 |
| foster and thrive ibuprofen pm | DIPHENHYDRAMINE CITRATE, IBUPROFEN | Strategic Sourcing Services LLC | 8691e397-e598-4e23-a389-2dbbb8f4496a | 2023-11-01 | Warnings | 079113 ANDA079113 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-0050 | good sense ibuprofen pm | diphenhydramine citrate, ibuprofen | L. Perrigo Company | ANDA | Current |
| 0113-0050 | good sense ibuprofen pm | diphenhydramine citrate, ibuprofen | L. Perrigo Company | ANDA | Current |
| 0363-0050 | Ibuprofen PM | diphenhydramine citrate, ibuprofen | Walgreen Company | ANDA | Current |
| 0363-0050 | Ibuprofen PM | diphenhydramine citrate, ibuprofen | Walgreen Company | ANDA | Current |
| 0363-0050 | Ibuprofen PM | diphenhydramine citrate, ibuprofen | Walgreen Company | ANDA | Current |
| 0363-0413 | Ibuprofen | Diphenhydramine citrate, Ibuprofen | Walgreen Company | ANDA | Current |
| 10202-050 | 7 Select Ibuprofen PM | diphenhydramine citrate, ibuprofen | 7-Eleven | ANDA | Current |
| 10202-050 | 7 Select Ibuprofen PM | diphenhydramine citrate, ibuprofen | 7-Eleven | ANDA | Current |
| 11673-050 | up and up ibuprofen pm | diphenhydramine citrate and ibuprofen | Target Corporation | ANDA | Current |
| 11673-050 | up and up ibuprofen pm | diphenhydramine citrate and ibuprofen | Target Corporation | ANDA | Current |
| 11673-050 | up and up ibuprofen pm | diphenhydramine citrate and ibuprofen | Target Corporation | ANDA | Current |
| 11822-0050 | ibuprofen pm | Diphenhydramine Citrate, Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-0050 | ibuprofen pm | Diphenhydramine Citrate, Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 21130-030 | Signature Care Ibuprofen PM | Diphenhydramine citrate, Ibuprofen | Safeway | ANDA | Current |
| 21130-030 | Signature Care Ibuprofen PM | Diphenhydramine citrate, Ibuprofen | Safeway | ANDA | Current |
| 21130-283 | Signature Care Ibuprofen PM | diphenhydramine citrate, ibuprofen | Safeway | ANDA | Current |
| 21130-283 | Signature Care Ibuprofen PM | diphenhydramine citrate, ibuprofen | Safeway | ANDA | Current |
| 24385-937 | Good Neighbor Pharmacy Ibuprofen PM | diphenhydramine citrate, ibuprofen | Amerisource Bergen | ANDA | Current |
| 24385-937 | Good Neighbor Pharmacy Ibuprofen PM | diphenhydramine citrate, ibuprofen | Amerisource Bergen | ANDA | Current |
| 24385-937 | Good Neighbor Pharmacy Ibuprofen PM | diphenhydramine citrate, ibuprofen | Amerisource Bergen | ANDA | Current |
| 30142-050 | ibuprofen pm | diphenhydramine citrate and ibuprofen | Kroger Company | ANDA | Current |
| 30142-050 | ibuprofen pm | diphenhydramine citrate and ibuprofen | Kroger Company | ANDA | Current |
| 30142-050 | ibuprofen pm | diphenhydramine citrate and ibuprofen | Kroger Company | ANDA | Current |
| 36800-050 | Topcare Ibuprofen PM | diphenhydramine citrate and ibuprofen | Topco Associates LLC | ANDA | Current |
| 36800-050 | Topcare Ibuprofen PM | diphenhydramine citrate and ibuprofen | Topco Associates LLC | ANDA | Current |
| 36800-050 | Topcare Ibuprofen PM | diphenhydramine citrate and ibuprofen | Topco Associates LLC | ANDA | Current |
| 37012-050 | Ibuprofen PM | diphenhydramine citrate, ibuprofen | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-050 | Ibuprofen PM | diphenhydramine citrate, ibuprofen | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-360 | Leader ibuprofen pm | diphenhydramine citrate, ibuprofen | Cardinal Health | ANDA | Current |
| 37808-050 | rx act ibuprofen pm | diphenhydramine citrate, ibuprofen | H E B | ANDA | Current |
| 37808-050 | rx act ibuprofen pm | diphenhydramine citrate, ibuprofen | H E B | ANDA | Current |
| 37808-703 | ibuprofen pm | diphenhydramine citrate, ibuprofen | H E B | ANDA | Current |
| 37808-703 | ibuprofen pm | diphenhydramine citrate, ibuprofen | H E B | ANDA | Current |
| 41163-050 | equaline ibuprofen pm | diphenhydramine citrate, ibuprofen | Supervalu Inc | ANDA | Current |
| 41163-050 | equaline ibuprofen pm | diphenhydramine citrate, ibuprofen | Supervalu Inc | ANDA | Current |
| 41163-561 | equaline ibuprofen pm | Diphenhydramine citrate, Ibuprofen | Supervalu Inc | ANDA | Current |
| 41190-050 | shoprite ibuprofen pm | diphenhydramine citrate, ibuprofen | Wakefern Food Corporation | ANDA | Current |
| 41190-050 | shoprite ibuprofen pm | diphenhydramine citrate, ibuprofen | Wakefern Food Corporation | ANDA | Current |
| 41250-050 | Ibuprofen PM | diphenhydramine citrate, ibuprofen | Meijer Distribution Inc | ANDA | Current |
| 41250-413 | ibuprofen pm | Diphenhydramine citrate, Ibuprofen | Meijer Distribution Inc | ANDA | Current |
| 41250-413 | ibuprofen pm | Diphenhydramine citrate, Ibuprofen | Meijer Distribution Inc | ANDA | Current |
| 41520-050 | Care One Ibuprofen PM | diphenhydramine citrate and ibuprofen | American Sales Company | ANDA | Current |
| 41520-050 | Care One Ibuprofen PM | diphenhydramine citrate and ibuprofen | American Sales Company | ANDA | Current |
| 41520-413 | careone ibuprofen pm | Diphenhydramine citrate, Ibuprofen | American Sales Company | ANDA | Current |
| 42507-050 | ibuprofen pm | diphenhydramine citrate, ibuprofen | HyVee Inc | ANDA | Current |
| 46122-145 | good neighbor pharmacy ibuprofen pm | Diphenhydramine citrate, Ibuprofen | Amerisource Bergen | ANDA | Current |
| 46122-708 | good neighbor pharmacy ibuprofen pm | diphenhydramine citrate, ibuprofen | Amerisource Bergen | ANDA | Current |
| 49035-699 | equate ibuprofen pm | diphenhydramine citrate, ibuprofen | Wal-Mart Stores Inc | ANDA | Current |
| 49035-699 | equate ibuprofen pm | diphenhydramine citrate, ibuprofen | Wal-Mart Stores Inc | ANDA | Current |
| 49348-873 | sunmark ibuprofen pm | diphenhydramine citrate and ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-873 | sunmark ibuprofen pm | diphenhydramine citrate and ibuprofen | McKesson | ANDA | Current |
| 49348-873 | sunmark ibuprofen pm | diphenhydramine citrate and ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 49738-191 | smart sense ibuprofen pm | diphenhydramine citrate, ibuprofen | Kmart Corporation | ANDA | Current |
| 49738-191 | smart sense ibuprofen pm | diphenhydramine citrate, ibuprofen | Kmart Corporation | ANDA | Current |
| 50580-563 | Motrin | Ibuprofen and Diphenhydramine Citrate | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-563 | Motrin | Ibuprofen and Diphenhydramine Citrate | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-563 | Motrin | Ibuprofen and Diphenhydramine Citrate | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 55301-050 | Exchange Select Ibuprofen PM | diphenhydramine citrate, ibuprofen | Army & Air Force Exchange Service | ANDA | Current |
| 55301-050 | Exchange Select Ibuprofen PM | diphenhydramine citrate, ibuprofen | Army & Air Force Exchange Service | ANDA | Current |
| 55316-050 | healthy accents ibuprofen pm | diphenhydramine citrate, ibuprofen | DZA Brands LLC | ANDA | Current |
| 55319-050 | family wellness ibuprofen pm | diphenhydramine citrate, ibuprofen | Family Dollar Services Inc | ANDA | Current |
| 55319-050 | ibuprofen pm | diphenhydramine citrate, ibuprofen | Family Dollar Services Inc | ANDA | Current |
| 55319-050 | family wellness ibuprofen pm | diphenhydramine citrate, ibuprofen | Family Dollar Services Inc | ANDA | Current |
| 55910-050 | dg health Ibuprofen pm | diphenhydramine citrate and ibuprofen | Dolgencorp Inc | ANDA | Current |
| 55910-050 | dg health Ibuprofen pm | diphenhydramine citrate and ibuprofen | Dolgencorp Inc | ANDA | Current |
| 55910-050 | dg health Ibuprofen pm | diphenhydramine citrate and ibuprofen | Dolgencorp Inc | ANDA | Current |
| 55910-050 | dg health Ibuprofen pm | diphenhydramine citrate and ibuprofen | Dolgencorp Inc | ANDA | Current |
| 55910-413 | DG Health Ibuprofen | Diphenhydramine citrate, Ibuprofen | Dolgencorp, LLC | ANDA | Current |
| 55910-413 | DG Health Ibuprofen | Diphenhydramine citrate, Ibuprofen | Dolgencorp, LLC | ANDA | Current |
| 56062-050 | ibuprofen pm | diphenhydramine citrate, ibuprofen | Publix Super Markets Inc | ANDA | Current |
| 59779-050 | ibuprofen pm | diphenhydramine citrate and ibuprofen | CVS Pharmacy | ANDA | Current |
| 59779-050 | ibuprofen pm | diphenhydramine citrate and ibuprofen | CVS Pharmacy | ANDA | Current |
| 59779-413 | ibuprofen pm | Diphenhydramine citrate, Ibuprofen | CVS Pharmacy | ANDA | Current |
| 62011-0335 | Health Mart ibuprofen PM | diphenhydramine citrate, ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0335 | Health Mart ibuprofen PM | diphenhydramine citrate, ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0335 | Health Mart ibuprofen PM | diphenhydramine citrate, ibuprofen | Mckesson | ANDA | Current |
| 68391-050 | berkley and jensen ibuprofen pm | diphenhydramine citrate, ibuprofen | BJWC | ANDA | Current |
| 68391-050 | berkley and jensen ibuprofen pm | diphenhydramine citrate, ibuprofen | BJWC | ANDA | Current |
| 69256-050 | Harris Teeter Ibuprofen PM | diphenhydramine citrate, ibuprofen | Harris Teeter, LLC | ANDA | Current |
| 69256-050 | Harris Teeter Ibuprofen PM | diphenhydramine citrate, ibuprofen | Harris Teeter, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22634 | ORIG | 2012-03-28 |