Fiorinal

Product NDC: 52544-955
11-digit product format: 525440955
Labeler code: 52544
Product ID: 52544-955_d764eacb-cdb8-45a3-ad91-429b6c3f573b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Aspirin, and Caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA017534
Marketing category: NDA
Marketing start: 1976-05-04
Marketing end: 2020-01-31
Substance: BUTALBITAL; ASPIRIN; CAFFEINE
Active strength: 50 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [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: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52544-955		D	Discontinued by firm		2026-10-05
excluded package	package	52544-955	52544-955-01	D	Discontinued by firm		2026-10-05

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 · 24 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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`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	52544-955-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017534-003	FIORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16
N017534-005	FIORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD	1986-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017534-003	FIORINAL	325MG;50MG;40MG	TABLET / ORAL		RLD	1986-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD, RS	1986-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017534-003	FIORINAL	325MG;50MG;40MG	TABLET / ORAL		RLD	1986-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD, RS	1986-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1986-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD, RS	1986-04-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017534-005	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017534-005	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017534-005	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017534-005	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017534-005	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017534-005	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017534-005	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017534-005	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017534-005	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017534-005	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017534-005	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017534-005	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017534-005	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52544-955-01	EA - Each	52544-955	d01f2a0d-0709-4c5d-8ff5-d76d7346aab8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FIORINAL (BUTALBITAL, ASPIRIN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fiorinal ® ( Butalbital, Aspirin, and Caffeine Capsules, USP ) C-III Revised: February 2014 Rx only 190104-1	Actavis Pharma, Inc.	2018-11-14	HUMAN PRESCRIPTION DRUG LABEL	9