Acetaminophen Aspirin Caffeine

Product NDC: 75907-432
11-digit product format: 759070432
Labeler code: 75907
Product ID: 75907-432_9f2bd060-918c-218f-4ecd-7842d293367f
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen Aspirin Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA214039
Marketing category: ANDA
Marketing start: 2026-09-25
Substance: ACETAMINOPHEN; CAFFEINE; ASPIRIN
Active strength: 250; 65; 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:34	2026-08	A214039-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2021-02-23	`84e616aacf4f…`
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…`

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: Acetaminophen Aspirin Caffeine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	250 mg/1
CAFFEINE	65 mg/1
ASPIRIN	250 mg/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 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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1154258	acetaminophen / aspirin / caffeine Pill	acetaminophen / aspirin / caffeine Pill	SCDG Active

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
75907-432-01	75907043201	1 BOTTLE in 1 CARTON (75907-432-01) / 100 TABLET in 1 BOTTLE	1 bottle	2026-09-25	No	No	Current
75907-432-02	75907043202	200 TABLET in 1 BOTTLE (75907-432-02)	200 tablet	2026-09-25	No	No	Current

Acetaminophen Aspirin Caffeine

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#

Additional Listing Data#

Active Ingredients#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related RxNorm Concepts#

Packages#

Related DailyMed Labels#