Vanatol

Product NDC: 58809-820
11-digit product format: 588090820
Labeler code: 58809
Product ID: 58809-820_9686027a-6244-9330-e053-2a95a90a0319
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: SYRUP
Route: ORAL
Labeler: GM Pharmaceuticals
Application: ANDA040387
Marketing category: ANDA
Marketing start: 2015-04-28
Marketing end: 0000-00-00
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength: 50 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes: Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2020-12-31
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	58809-820		D	Discontinued by firm	2026-08-11
excluded package	package	58809-820	58809-820-02	D	Discontinued by firm	2026-08-11
excluded package	package	58809-820	58809-820-16	D	Discontinued by firm	2026-08-11

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 · 36 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	58809-820-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58809-820-02	`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	58809-820-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58809-820-02	`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	58809-820-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58809-820-02	`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	58809-820-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58809-820-02	`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	58809-820-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58809-820-02	`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	58809-820-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58809-820-02	`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	58809-820-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58809-820-02	`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	58809-820-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58809-820-02	`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	58809-820-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58809-820-02	`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	58809-820-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58809-820-02	`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	58809-820-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58809-820-02	`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	58809-820-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58809-820-02	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL		RS	2003-01-31

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-820-16	ML - Milliliter	58809-820	c7c8884c-b662-4596-969d-113a1ae54f69	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
ETHYL MALTOL	INACTIVE INGREDIENT	L6Q8K29L05	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VANATOL LQ (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) SYRUP [GM PHARMACEUTICALS]	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 · 1 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	Genus Lifesciences Inc.	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040387 application number: ANDA040387

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