Migraine Relief

Product NDC
63868-316
11-digit product format
638680316
Labeler code
63868
Product ID
63868-316_ee299f62-f505-5e30-e053-2995a90a3c41
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, ASPIRIN and CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA214039
Marketing category
ANDA
Marketing start
2022-05-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 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
2023-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-316DDiscontinued by firm2026-08-17
excluded packagepackage63868-31663868-316-24DDiscontinued by firm2026-08-17

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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct63868-316DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63868-31663868-316-24DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINEACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2387673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23a50c72e98297…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-316MIGRAINE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]3Legacy NDC20241013_4ec0f9e7-a533-4084-a03a-24c25132435a.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.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEHARRIS TEETERff32572c-393b-0b49-e053-6394a90a83da2026-08-05WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)bfcffa70-94a9-43de-9f22-4ed6a71c0a8d2026-01-29WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINESafeway, Incf2a2cbb5-5a63-7514-e053-2995a90a572c2025-12-19WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Acetaminophen Aspirin CaffeineACETAMINOPHEN ASPIRIN CAFFEINECVS PHARMACY, INCc340c5ef-e15d-53ce-e053-2995a90a73e72025-12-19WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Acetaminophen Aspirin CaffeineACETAMINOPHEN ASPIRIN CAFFEINEWALGREEN COc32c8cbd-5775-afe3-e053-2995a90a81cb2025-12-19WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINEFAMILY DOLLARf837e190-6fb3-e22e-e053-6394a90a12e62025-12-19WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINEGranules India Ltde9534a13-ee8f-470f-8dd1-8ef0ce68526a2025-12-01WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
PUBLIX SUPER MARKETS INCACETAMINOPHEN, ASPIRIN AND CAFFEINEPUBLIX SUPER MARKETS INC08a46808-2bb2-0b40-e063-6394a90af80e2025-01-02WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION, INC.a6a07615-3108-436f-bbce-be7cb89ce4562024-06-13WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEDISCOUNT DRUG MART0ac12ced-70b3-7bbe-e063-6394a90aad522024-06-13WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINESafrel Pharmaceuticals, LLC.0ac07846-5f04-dc4b-e063-6394a90ac8ca2023-11-22WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEAAA PHARMACEUTICAL, INC.f9c9a0b4-dbfe-7da9-e053-6294a90a7e092023-05-03WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEFSA STORE INC.ec6b7017-cf12-09a7-e053-2995a90a2db92023-01-12WarningsExact identifier
application applno (ANDA): 214039
application number: ANDA214039

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-316-24638680316241 BOTTLE, PLASTIC in 1 CARTON (63868-316-24) > 24 TABLET in 1 BOTTLE, PLASTIC2022-05-050000-00-00NoNoCurrent