Orphenadrine Citrate Aspirin Caffeine

Product NDC: 50564-554
11-digit product format: 505640554
Labeler code: 50564
Product ID: 50564-554_71f2aff4-c5dd-4a71-b740-30a94acc9e10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate, Aspirin, Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Jerome Stevens Pharmaceuticals, Inc.
Application: ANDA074988
Marketing category: ANDA
Marketing start: 1999-04-30
Marketing end: 0000-00-00
Substance: ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE
Active strength: 25 mg/1; mg/1; mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [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]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50564-554		I	Inactivated by FDA	2026-08-17
excluded package	package	50564-554	50564-554-01	I	Inactivated by FDA	2026-08-17
excluded package	package	50564-554	50564-554-05	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 1 · 18 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
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	50564-554-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50564-554-05	`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	50564-554-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50564-554-05	`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	50564-554-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50564-554-05	`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	50564-554-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50564-554-05	`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	50564-554-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50564-554-05	`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	50564-554-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50564-554-05	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	385MG;30MG;25MG	TABLET / ORAL			1999-04-30
A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	770MG;60MG;50MG	TABLET / ORAL			1999-04-30

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074988-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL	1999-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074988-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	1999-04-30	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50564-554-01	2026-01-29	ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS
50564-554-05	2026-01-29	ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS
50564-554-01	2024-12-05	ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS
50564-554-05	2024-12-05	ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS
50564-554-01	2023-01-30	ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS
50564-554-05	2023-01-30	ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50564-554-01	Orphenadrine Citrate Aspirin Caffeine	100 in 1 BOTTLE	TABLET	100		4
50564-554-05	Orphenadrine Citrate Aspirin Caffeine	500 in 1 BOTTLE	TABLET	500		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50564-554	ORPHENADRINE CITRATE ASPIRIN CAFFEINE (ORPHENADRINE CITRATE, ASPIRIN, CAFFEINE) TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]	4	Legacy NDC, 2 package rows	20241207_b49dd596-1f6a-4ff7-8079-e55bbcca8fbd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X0A40N8I4S	ORPHENADRINE CITRATE	4682-36-4	ORPHENADRINE CITRATE
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
994528	orphenadrine citrate 25 MG / aspirin 385 MG / caffeine 30 MG Oral Tablet	PSN	b49dd596-1f6a-4ff7-8079-e55bbcca8fbd	4
994535	orphenadrine citrate 50 MG / aspirin 770 MG / caffeine 60 MG Oral Tablet	PSN	b49dd596-1f6a-4ff7-8079-e55bbcca8fbd	4
994528	aspirin 385 MG / caffeine 30 MG / orphenadrine citrate 25 MG Oral Tablet	SCD	b49dd596-1f6a-4ff7-8079-e55bbcca8fbd	4
994535	aspirin 770 MG / caffeine 60 MG / orphenadrine citrate 50 MG Oral Tablet	SCD	b49dd596-1f6a-4ff7-8079-e55bbcca8fbd	4
994528	ASA 385 MG / Caffeine 30 MG / Orphenadrine Citrate 25 MG Oral Tablet	SY	b49dd596-1f6a-4ff7-8079-e55bbcca8fbd	4
994535	ASA 770 MG / caffeine 60 MG / orphenadrine citrate 50 MG Oral Tablet	SY	b49dd596-1f6a-4ff7-8079-e55bbcca8fbd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50564-554-01	50564055401	100 TABLET in 1 BOTTLE (50564-554-01)	100 tablet	1999-04-30	0000-00-00	No	No	Current
50564-554-05	50564055405	500 TABLET in 1 BOTTLE (50564-554-05)	500 tablet	1999-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS	Jerome Stevens Pharmaceuticals, Inc.	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	4