Application 214039

Type: ANDA
Sponsor: GRANULES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	TABLET;ORAL	250MG;250MG;65MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL			2021-02-23

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Migraine Relief	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	HARRIS TEETER	ff32572c-393b-0b49-e053-6394a90a83da	2026-08-05	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Migraine Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	bfcffa70-94a9-43de-9f22-4ed6a71c0a8d	2026-01-29	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Safeway, Inc	f2a2cbb5-5a63-7514-e053-2995a90a572c	2025-12-19	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Acetaminophen Aspirin Caffeine	ACETAMINOPHEN ASPIRIN CAFFEINE	CVS PHARMACY, INC	c340c5ef-e15d-53ce-e053-2995a90a73e7	2025-12-19	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039 ndc (product): 69842-680
Acetaminophen Aspirin Caffeine	ACETAMINOPHEN ASPIRIN CAFFEINE	WALGREEN CO	c32c8cbd-5775-afe3-e053-2995a90a81cb	2025-12-19	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039 ndc (product): 0363-9680
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	FAMILY DOLLAR	f837e190-6fb3-e22e-e053-6394a90a12e6	2025-12-19	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Granules India Ltd	e9534a13-ee8f-470f-8dd1-8ef0ce68526a	2025-12-01	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039 ndc (product): 62207-680
PUBLIX SUPER MARKETS INC	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	PUBLIX SUPER MARKETS INC	08a46808-2bb2-0b40-e063-6394a90af80e	2025-01-02	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Migraine Relief	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	a6a07615-3108-436f-bbce-be7cb89ce456	2024-06-13	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Migraine Relief	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	DISCOUNT DRUG MART	0ac12ced-70b3-7bbe-e063-6394a90aad52	2024-06-13	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Safrel Pharmaceuticals, LLC.	0ac07846-5f04-dc4b-e063-6394a90ac8ca	2023-11-22	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Migraine Relief	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	AAA PHARMACEUTICAL, INC.	f9c9a0b4-dbfe-7da9-e053-6294a90a7e09	2023-05-03	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039
Migraine Relief	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	FSA STORE INC.	ec6b7017-cf12-09a7-e053-2995a90a2db9	2023-01-12	Warnings	Exact identifier application applno (ANDA): 214039 application number: ANDA214039 ndc (product): 81522-205

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9680	Acetaminophen Aspirin Caffeine	Acetaminophen Aspirin Caffeine	WALGREEN CO	ANDA	Current
62207-680	Acetaminophen, Aspirin and Caffeine	Acetaminophen, Aspirin and Caffeine	Granules India Ltd	ANDA	Current
62207-680	Acetaminophen, Aspirin and Caffeine	Acetaminophen, Aspirin and Caffeine	Granules India Ltd	ANDA	Current
63868-316	Migraine Relief	ACETAMINOPHEN, ASPIRIN and CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
69842-680	Acetaminophen Aspirin Caffeine	Acetaminophen Aspirin Caffeine	CVS PHARMACY, INC	ANDA	Current
81522-205	Migraine Relief	ACETAMINOPHEN, ASPIRIN and CAFFEINE	FSA STORE INC.	ANDA	Current