Leader migraine formula
- Product NDC
- 70518-0321
- 11-digit product format
- 705180321
- Labeler code
- 70518
- Product ID
- 70518-0321_4adfa75f-d0c0-48d1-e054-00144ff8d46c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin, Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075794
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250 mg/1; mg/1; mg/1
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-0321 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-0321 | 70518-0321-0 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0321-0 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 70518-0321-0 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | 250MG;250MG;65MG | TABLET / ORAL | 2001-11-26 | caaa826d4ba7… | ||
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-0321-0 | 2020-03-31 | C162847 | 48780-1 | 9d75b9d0-d927-f424-e053-dadaa90a57ce | Cardinal Health Migraine Formula Drug Facts |
| 70518-0321-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d927-f424-e053-dadaa90a57ce | Cardinal Health Migraine Formula Drug Facts |
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 |
|---|---|---|---|---|---|---|
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreen Company | 36503181-0fda-4127-b3f0-bdb1b56bb0ed | 2026-08-24 | Warnings | 075794 ANDA075794 |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Rite Aid Corporation | 80e58390-69fb-48f7-ad3a-a13f125cd921 | 2026-05-27 | Warnings | 075794 ANDA075794 |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | f052512b-e55a-4369-8c9c-453c9a5686a3 | 2026-05-13 | Warnings | 075794 ANDA075794 |
| migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | HyVee Inc | 76e21832-5c4c-4c73-9f87-1060abbd3d82 | 2026-05-08 | Warnings | 075794 ANDA075794 |
| Up and Up Migraine Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Target Corporation | acaffae6-2964-4529-b61a-19ddfc5fd669 | 2026-04-29 | Warnings | 075794 ANDA075794 |
| Care One migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | American Sales Company | be6c9dc5-853e-4342-ba6a-e5b7be5afe72 | 2026-04-09 | Warnings | 075794 ANDA075794 |
| MIGRAINE FORMULA | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Meijer, Inc. | 529b6ee6-043c-430a-b2e1-b63c81f10291 | 2026-04-08 | Warnings | 075794 ANDA075794 |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Sportpharm LLC | 2a27da49-23d6-4035-8088-806ee22b98b0 | 2026-03-06 | Warnings | 075794 ANDA075794 |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | CVS Pharmacy | e130831a-ec50-467a-9e5c-ba6ebc7bef3c | 2026-02-26 | Warnings | 075794 ANDA075794 |
| Leader Migraine Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Cardinal Health 110, LLC. dba Leader | b74a8baa-c7a2-4eed-8202-888d8ba829b9 | 2026-01-20 | Warnings | 075794 ANDA075794 |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | 93e7ba56-5682-4184-9a93-3b4b972b0e72 | 2025-11-10 | Warnings | 075794 ANDA075794 |
| migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | H E B | f2f9b930-7b54-46c5-8631-d673a52a9eb4 | 2025-09-19 | Warnings | 075794 ANDA075794 |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreen Company | 5dcc2b01-6556-46bc-a451-f09dd0bd1eed | 2025-09-04 | Warnings | 075794 ANDA075794 |
| Topcare Migraine Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Topco Associates LLC | a2a9fbec-639f-4002-aa34-51b4563fc38e | 2025-09-04 | Warnings | 075794 ANDA075794 |
| Equaline migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | United Natural Foods, Inc. dba UNFI | 28ab87e5-6b7d-4737-95e8-4f842ecd9408 | 2025-08-28 | Warnings | 075794 ANDA075794 |
| good neighbor pharmacy migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Amerisource Bergen | 201f101a-3b53-4349-896c-6b86cdd9b831 | 2025-08-26 | Warnings | 075794 ANDA075794 |
| migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Meijer Distribution Inc | 8f1ee554-1021-4613-ba0e-aa02f8a751f8 | 2025-06-16 | Warnings | 075794 ANDA075794 |
| foster and thrive migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strategic Sourcing Services LLC | fe9bf032-fc8b-4b2d-8c6b-acdbe1f320bf | 2025-06-11 | Warnings | 075794 ANDA075794 |
| Signature Care Migraine Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Safeway | 66695667-97a3-4329-8ce0-0fffa8628951 | 2024-03-27 | Warnings | 075794 ANDA075794 |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Proficient Rx LP | ed491286-f756-42f7-9a35-ea0380d1ff58 | 2023-08-01 | Warnings | 075794 ANDA075794 |