Application 075794
- Type
- ANDA
- Sponsor
- PERRIGO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | TABLET;ORAL | 250MG;250MG;65MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 |
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 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | cb3db0bc1861… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-0374 | good sense migraine formula | Acetaminophen, Aspirin, Caffeine | L. Perrigo Company | ANDA | Current |
| 0113-0374 | good sense migraine formula | Acetaminophen, Aspirin, Caffeine | L. Perrigo Company | ANDA | Current |
| 0113-1619 | good sense migraine formula | acetaminophen, aspirin, caffeine | L. Perrigo Company | ANDA | Current |
| 0113-7374 | basic care migraine relief | Acetaminophen, Aspirin, Caffeine | L. Perrigo Company | ANDA | Current |
| 0363-0374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Walgreen Company | ANDA | Current |
| 0363-0374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Walgreen Company | ANDA | Current |
| 0363-0374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Walgreen Company | ANDA | Current |
| 0363-1235 | migraine relief | acetaminophen, aspirin, caffeine | Walgreen Company | ANDA | Current |
| 10202-374 | 7 Select Migraine Formula | Acetaminophen, Aspirin, Caffeine | 7-Eleven | ANDA | Current |
| 10202-374 | 7 Select Migraine Formula | Acetaminophen, Aspirin, Caffeine | 7-Eleven | ANDA | Current |
| 11673-374 | Up and Up Migraine Relief | Acetaminophen, Aspirin, Caffeine | Target Corporation | ANDA | Current |
| 11822-0374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Rite Aid Corporation | ANDA | Current |
| 11822-0374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Rite Aid Corporation | ANDA | Current |
| 11822-0374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Rite Aid Corporation | ANDA | Current |
| 11822-1121 | migraine relief | Acetaminophen, Aspirin, Caffeine | Rite Aid Corporation | ANDA | Current |
| 21130-569 | Signature Care Migraine Relief | Acetaminophen, Aspirin, Caffeine | Safeway | ANDA | Current |
| 21130-569 | Signature Care Migraine Relief | Acetaminophen, Aspirin, Caffeine | Safeway | ANDA | Current |
| 24385-365 | good neighbor pharmacy migraine relief | Acetaminophen, Aspirin, Caffeine | Amerisource Bergen | ANDA | Current |
| 24385-365 | good neighbor pharmacy migraine relief | Acetaminophen, Aspirin, Caffeine | Amerisource Bergen | ANDA | Current |
| 30142-374 | migraine formula | Acetaminophen, Aspirin, Caffeine | Kroger Company | ANDA | Current |
| 30142-374 | migraine formula | Acetaminophen, Aspirin, Caffeine | Kroger Company | ANDA | Current |
| 30142-896 | migraine relief | acetaminophen, aspirin, caffeine | Kroger Company | ANDA | Current |
| 30142-896 | migraine relief | acetaminophen, aspirin, caffeine | Kroger Company | ANDA | Current |
| 36800-374 | Topcare Migraine Formula | Acetaminophen, Aspirin, Caffeine | Topco Associates LLC | ANDA | Current |
| 36800-374 | Topcare Migraine Formula | Acetaminophen, Aspirin, Caffeine | Topco Associates LLC | ANDA | Current |
| 36800-533 | Topcare Migraine Relief | Acetaminophen, Aspirin, Caffeine | Topco Associates LLC | ANDA | Current |
| 36800-533 | Topcare Migraine Relief | Acetaminophen, Aspirin, Caffeine | Topco Associates LLC | ANDA | Current |
| 36800-533 | Topcare Migraine Relief | Acetaminophen, Aspirin, Caffeine | Topco Associates LLC | ANDA | Current |
| 36800-934 | topcare migraine relief | Acetaminophen, Aspirin, Caffeine | Topco Associates LLC | ANDA | Current |
| 37012-374 | Migraine Relief | Acetaminophen, Aspirin, Caffeine | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-374 | Migraine Relief | Acetaminophen, Aspirin, Caffeine | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37808-374 | migraine formula | Acetaminophen, Aspirin, Caffeine | H E B | ANDA | Current |
| 37808-374 | migraine formula | Acetaminophen, Aspirin, Caffeine | H E B | ANDA | Current |
| 41163-374 | Equaline migraine formula | Acetaminophen, Aspirin, Caffeine | Supervalu Inc | ANDA | Current |
| 41163-374 | Equaline migraine formula | Acetaminophen, Aspirin, Caffeine | Supervalu Inc | ANDA | Current |
| 41190-374 | ShopRite Migraine Formula | Acetaminophen, Aspirin, Caffeine | Wakefern Food Corporation | ANDA | Current |
| 41190-374 | ShopRite Migraine Formula | Acetaminophen, Aspirin, Caffeine | Wakefern Food Corporation | ANDA | Current |
| 41250-374 | migraine formula | Acetaminophen, Aspirin, Caffeine | Meijer Distribution Inc | ANDA | Current |
| 41250-374 | migraine formula | Acetaminophen, Aspirin, Caffeine | Meijer Distribution Inc | ANDA | Current |
| 41520-374 | Care One migraine relief | Acetaminophen, Aspirin, Caffeine | American Sales Company | ANDA | Current |
| 41520-374 | Care One migraine relief | Acetaminophen, Aspirin, Caffeine | American Sales Company | ANDA | Current |
| 42961-202 | Xpect Pain Away | Pain Reliever | Cintas Corporation | ANDA | Current |
| 49348-506 | Sunmark migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-506 | Sunmark migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-506 | Sunmark migraine relief | Acetaminophen, Aspirin, Caffeine | McKesson | ANDA | Current |
| 49348-506 | Sunmark migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-506 | Sunmark migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 49738-374 | Smart Sense migraine relief | Acetaminophen, Aspirin, Caffeine | Kmart Corporation | ANDA | Current |
| 49738-374 | Smart Sense migraine relief | Acetaminophen, Aspirin, Caffeine | Kmart Corporation | ANDA | Current |
| 49738-444 | Smart Sense Migraine Formula | Acetaminophen, Aspirin, Caffeine | Kmart Corporation | ANDA | Current |
| 49738-444 | Smart Sense Migraine Formula | Acetaminophen, Aspirin, Caffeine | Kmart Corporation | ANDA | Current |
| 50594-374 | sound body migraine relief | Acetaminophen, Aspirin, Caffeine | Big Lots Stores, Inc. | ANDA | Current |
| 55316-374 | Healthy Accents migraine formula | Acetaminophen, Aspirin, Caffeine | DZA Brands LLC | ANDA | Current |
| 55316-374 | Healthy Accents migraine formula | Acetaminophen, Aspirin, Caffeine | DZA Brands LLC | ANDA | Current |
| 55319-374 | Family Wellness Migraine Relief | Acetaminophen, Aspirin, Caffeine | Family Dollar Services Inc | ANDA | Current |
| 55319-553 | family wellness migraine | Acetaminophen, Aspirin, Caffeine | Family Dollar Services Inc | ANDA | Current |
| 55319-553 | family wellness migraine | Acetaminophen, Aspirin, Caffeine | Family Dollar Services Inc | ANDA | Current |
| 55910-374 | DG Health migraine relief | Acetaminophen, Aspirin, Caffeine | Dolgencorp, LLC | ANDA | Current |
| 55910-374 | DG Health migraine relief | Acetaminophen, Aspirin, Caffeine | Dolgencorp, LLC | ANDA | Current |
| 55910-374 | DG Health migraine relief | Acetaminophen, Aspirin, Caffeine | Dolgencorp, LLC | ANDA | Current |
| 55910-448 | dg health migraine relief | acetaminophen, aspirin, caffeine | Dolgencorp Inc | ANDA | Current |
| 56062-374 | migraine relief | Acetaminophen, Aspirin, Caffeine | Publix Super Markets Inc | ANDA | Current |
| 59779-374 | migraine relief | acetaminophen, aspirin, caffeine | CVS Pharmacy | ANDA | Current |
| 59779-374 | migraine relief | acetaminophen, aspirin, caffeine | CVS Pharmacy | ANDA | Current |
| 62011-0243 | health mart migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0243 | health mart migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0243 | health mart migraine relief | Acetaminophen, Aspirin, Caffeine | McKesson | ANDA | Current |
| 62011-0463 | health mart migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0463 | health mart migraine relief | Acetaminophen, Aspirin, Caffeine | Strategic Sourcing Services LLC | ANDA | Current |
| 63981-374 | kirkland signature migraine relief | Acetaminophen, Aspirin, Caffeine | Costco Wholesale Company | ANDA | Current |
| 63981-374 | kirkland signature migraine relief | Acetaminophen, Aspirin, Caffeine | Costco Wholesale Company | ANDA | Current |
| 63981-699 | kirkland signature migraine headache relief | Acetaminophen, Aspirin, Caffeine | Costco Wholesale Company | ANDA | Current |
| 66715-9738 | Lil Drug Store Headache Relief | Acetaminophen, Aspirin, and Caffeine | Lil' Drug Store Products, Inc. | ANDA | Current |
| 66715-9738 | Lil Drug Store Headache Relief | Acetaminophen, Aspirin, and Caffeine | Lil' Drug Store Products, Inc. | ANDA | Current |
| 66715-9738 | Lil Drug Store Headache Relief | Acetaminophen, Aspirin, and Caffeine | Lil' Drug Store Products, Inc. | ANDA | Current |
| 68071-2723 | good sense migraine formula | Acetaminophen, Aspirin, Caffeine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68391-536 | berkley and jensen migraine formula | Acetaminophen, Aspirin, Caffeine | BJWC | ANDA | Current |
| 69256-374 | harris teeter migraine relief | Acetaminophen, Aspirin, Caffeine | Harris Teeter, LLC | ANDA | Current |
| 70000-0247 | Leader Migraine Relief | Acetaminophen, Aspirin, Caffeine | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0247 | Leader Migraine Relief | Acetaminophen, Aspirin, Caffeine | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8792 | ORIG | 2003-04-15 |