berkley and jensen migraine formula

Product NDC
68391-536
11-digit product format
683910536
Labeler code
68391
Product ID
68391-536_084219c6-b1fc-49e2-bbcd-a9e0881819f4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA075794
Marketing category
ANDA
Marketing start
2014-02-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct68391-536DDiscontinued by firm2026-08-10
excluded packagepackage68391-53668391-536-85DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68391-536-85d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68391-536-85f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68391-536-852ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68391-536-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68391-536-85cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68391-536-85cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68391-536-85302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68391-536-85ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68391-536-850efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68391-536-85ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68391-536-85367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68391-536-85557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINEACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075794-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2001-11-26cb3db0bc1861…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
ASPIRINACTIVE MOIETYR16CO5Y76EBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
CAFFEINEACTIVE MOIETY3G6A5W338EBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN MIGRAINE FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [BJWC]1

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINERite Aid Corporation80e58390-69fb-48f7-ad3a-a13f125cd9212026-05-27WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Companyf052512b-e55a-4369-8c9c-453c9a5686a32026-05-13WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc76e21832-5c4c-4c73-9f87-1060abbd3d822026-05-08WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
Up and Up Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINETarget Corporationacaffae6-2964-4529-b61a-19ddfc5fd6692026-04-29WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
Care One migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerican Sales Companybe6c9dc5-853e-4342-ba6a-e5b7be5afe722026-04-09WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2a27da49-23d6-4035-8088-806ee22b98b02026-03-06WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacye130831a-ec50-467a-9e5c-ba6ebc7bef3c2026-02-26WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
Leader Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. dba Leaderb74a8baa-c7a2-4eed-8202-888d8ba829b92026-01-20WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company93e7ba56-5682-4184-9a93-3b4b972b0e722025-11-10WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2025-11-01WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEH E Bf2f9b930-7b54-46c5-8631-d673a52a9eb42025-09-19WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company5dcc2b01-6556-46bc-a451-f09dd0bd1eed2025-09-04WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
Topcare Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINETopco Associates LLCa2a9fbec-639f-4002-aa34-51b4563fc38e2025-09-04WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
Equaline migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFI28ab87e5-6b7d-4737-95e8-4f842ecd94082025-08-28WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
good neighbor pharmacy migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen201f101a-3b53-4349-896c-6b86cdd9b8312025-08-26WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer Distribution Inc8f1ee554-1021-4613-ba0e-aa02f8a751f82025-06-16WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEKroger Companyde57809f-d5f8-41b3-84d4-b2ef54e0f6d72025-06-11WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
foster and thrive migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrategic Sourcing Services LLCfe9bf032-fc8b-4b2d-8c6b-acdbe1f320bf2025-06-11WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794
Signature Care Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINESafeway66695667-97a3-4329-8ce0-0fffa86289512024-03-27WarningsExact identifier
application applno (ANDA): 075794
application number: ANDA075794