Butalbital, Acetaminophen, Caffeine

Product NDC: 85534-0046
11-digit product format: 855340046
Labeler code: 85534
Product ID: 85534-0046_56cb6d59-e749-3f7c-e063-6394a90a92e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA209587
Marketing category: ANDA
Marketing start: 2019-03-05
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength: 50; 325; 40 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule: CIII
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
A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209587-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209587-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209587-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209587-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209587-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209587-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209587-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209587-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209587-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209587-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209587-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209587-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209587-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209587-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209587-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209587-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209587-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209587-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209587-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209587-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209587-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209587-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209587-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209587-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209587-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209587-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209587-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209587-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209587-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209587-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209587-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209587-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209587-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209587-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209587-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209587-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209587-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209587-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209587-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209587-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209587-001	AA	1	`f41ea6bd6efb…`

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: Butalbital, Acetaminophen, Caffeine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTALBITAL	50 mg/1
ACETAMINOPHEN	325 mg/1
CAFFEINE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KHS0AZ4JVK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238154	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ab882f60-394c-4d4f-95f4-6b9d6d6b3193	Available on FDA.report

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	REMEDYREPACK INC.	dc2bb7fc-1722-4865-a02c-be5e5c211505	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	HAWAII REPACK, INC.	ab882f60-394c-4d4f-95f4-6b9d6d6b3193	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587 ndc (product): 85534-0046
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Preferred Pharmaceuticals Inc.	b121190e-db2a-43bb-a57d-b6683a9e2059	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Advanced Rx of Tennessee, LLC	4871c36f-229b-4c12-e063-6394a90a028e	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Asclemed USA, Inc.	cce09e09-158f-4927-8a3e-4ec9334f0b7a	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
BUTAL/APAP/CAFFEINE	BUTAL/APAP/CAFFEINE	Direct_Rx	2abb9915-edb2-6218-e063-6394a90ad462	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	AvPAK	e5fbd6b8-85e7-8847-e053-2a95a90a52ed	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Proficient Rx LP	3cf799b4-c785-4ae2-908b-c42e426733dc	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	e2978345-826a-47d2-acf3-feb6afb1967e	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	LGM PHARMA SOLUTIONS, LLC	f6548126-faa1-4f53-8e0b-bc1b743de04d	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	A-S Medication Solutions	f822c103-b678-4e76-8174-33b94421dd1e	2024-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Proficient Rx LP	d860af16-fab4-4263-9e66-a648d5e81dab	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	90e166ac-8789-4e7a-b5bb-37c475e3a5b0	2023-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Westminster Pharmaceuticals, LLC	1c0511d0-fe63-45c6-8da2-6ceeb56edb17	2019-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85534-0046-0	85534004600	10 TABLET in 1 BOTTLE (85534-0046-0)	10 tablet	2026-07-17	No	No	Current
85534-0046-1	85534004601	12 TABLET in 1 BOTTLE (85534-0046-1)	12 tablet	2026-07-17	No	No	Current
85534-0046-2	85534004602	20 TABLET in 1 BOTTLE (85534-0046-2)	20 tablet	2026-07-17	No	No	Current
85534-0046-3	85534004603	30 TABLET in 1 BOTTLE (85534-0046-3)	30 tablet	2026-07-17	No	No	Current
85534-0046-4	85534004604	60 TABLET in 1 BOTTLE (85534-0046-4)	60 tablet	2026-07-17	No	No	Current
85534-0046-5	85534004605	90 TABLET in 1 BOTTLE (85534-0046-5)	90 tablet	2026-07-17	No	No	Current
85534-0046-6	85534004606	100 TABLET in 1 BOTTLE (85534-0046-6)	100 tablet	2026-07-17	No	No	Current
85534-0046-7	85534004607	120 TABLET in 1 BOTTLE (85534-0046-7)	120 tablet	2026-07-17	No	No	Current
85534-0046-8	85534004608	500 TABLET in 1 BOTTLE (85534-0046-8)	500 tablet	2026-07-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg	HAWAII REPACK, INC.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	1