butalbital, acetaminophen and caffeine

Product NDC: 50436-4856
11-digit product format: 504364856
Labeler code: 50436
Product ID: 50436-4856_12f33220-6250-4b56-8758-94d2c51fbd11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA089175
Marketing category: ANDA
Marketing start: 1987-01-21
Marketing end: 0000-00-00
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength: 50 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-4856		I	Inactivated by FDA	2026-08-17
excluded package	package	50436-4856	50436-4856-1	I	Inactivated by FDA	2026-08-17
excluded package	package	50436-4856	50436-4856-2	I	Inactivated by FDA	2026-08-17

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-4856-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-4856-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-4856-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-4856-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-4856-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-4856-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-4856-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-4856-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-4856-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-4856-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-4856-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-4856-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-4856-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-4856-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-4856-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-4856-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-4856-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-4856-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-4856-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-4856-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-4856-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-4856-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-4856-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-4856-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-4856-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-4856-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-4856-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-4856-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-4856-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-4856-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-4856-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-4856-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-4856-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-4856-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-4856-2	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-4856-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-4856-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-4856-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50436-4856-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50436-4856-1	`e2bbac7714bc…`	`27bdfed8d636…`

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
A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1987-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A089175-001	AA

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089175-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089175-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089175-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089175-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089175-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089175-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089175-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089175-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089175-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089175-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089175-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089175-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089175-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089175-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089175-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089175-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089175-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089175-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089175-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089175-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089175-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089175-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089175-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089175-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089175-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089175-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089175-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089175-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089175-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089175-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089175-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089175-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089175-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089175-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089175-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089175-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089175-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089175-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089175-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089175-001	AA	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-4856-1	2020-01-31	C162847	48780-1	9d75b9d0-96bb-f424-e053-dadaa90a57ce	11690b28-5509-496a-9648-349158770ec2
50436-4856-2	2020-01-31	C162847	48780-1	9d75b9d0-96bb-f424-e053-dadaa90a57ce	11690b28-5509-496a-9648-349158770ec2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-4856-1	butalbital, acetaminophen and caffeine	30 in 1 BOTTLE	TABLET	30		2
50436-4856-2	butalbital, acetaminophen and caffeine	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-4856-1	EA - Each	50436-4856	78d46096-4a10-4c3c-9253-bc5739dfd23a	1	2013-07-02
50436-4856-2	EA - Each	50436-4856	76c5a9f7-552f-4359-bc77-c6d1ee63d2df	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-4856	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 2 package rows	20130614_11690b28-5509-496a-9648-349158770ec2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Chartwell RX, LLC	77776146-c6e6-478c-b30e-2b729e758400	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089175 application number: ANDA089175
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Mikart, LLC	a26775c2-cafb-4b13-99ac-d4e8248265fb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089175 application number: ANDA089175
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Proficient Rx LP	1bde13a5-cdd4-4bc2-8aeb-32e4dc157293	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089175 application number: ANDA089175

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238154	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet	PSN	11690b28-5509-496a-9648-349158770ec2	2
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	11690b28-5509-496a-9648-349158770ec2	2
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	11690b28-5509-496a-9648-349158770ec2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-4856-1	50436485601	30 in 1 BOTTLE	Historical
50436-4856-2	50436485602	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
butalbital, acetaminophen and caffeine - Unit Dose Services	Unit Dose Services	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	2