Signature Care Migraine Relief
- Product NDC
- 21130-569
- Requested package NDC
- 21130-569-85
- 11-digit product format
- 211300569
- Labeler code
- 21130
- Product ID
- 21130-569_1e6e02b1-e02b-470a-ab77-ffac79e5c7f6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin, Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safeway
- Application
- ANDA075794
- Marketing category
- ANDA
- Marketing start
- 2015-09-01
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250; 250; 65 mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 21130-569 | 21130-569-85 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Signature Care Migraine Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| ASPIRIN | 250 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| R16CO5Y76E | Internal UNII lookup |
| 3G6A5W338E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308297 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 66695667-97a3-4329-8ce0-0fffa8628951 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21130-569-62 | Signature Care Migraine Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 21130-569-62 | Signature Care Migraine Relief | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 6 | |
| 21130-569-71 | Signature Care Migraine Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 21130-569-71 | Signature Care Migraine Relief | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 6 | |
| 21130-569-78 | Signature Care Migraine Relief | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 6 | |
| 21130-569-78 | Signature Care Migraine Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 21130-569-85 | Signature Care Migraine Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 21130-569-85 | Signature Care Migraine Relief | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 66695667-97a3-4329-8ce0-0fffa8628951 | 6 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 66695667-97a3-4329-8ce0-0fffa8628951 | 6 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 66695667-97a3-4329-8ce0-0fffa8628951 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 21130-569-85 | 21130056985 | 1 BOTTLE in 1 CARTON (21130-569-85) > 250 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-01 | 0000-00-00 | No | No | Current |