Orphenadrine Citrate, Aspirin and Caffeine

Product NDC: 21695-726
11-digit product format: 216950726
Labeler code: 21695
Product ID: 21695-726_8e41b33e-f71f-4a5e-b88f-cdfefb2bee20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate, Aspirin and Caffeine
Dosage form: TABLET, MULTILAYER
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA074654
Marketing category: ANDA
Marketing start: 1996-12-31
Marketing end: 0000-00-00
Substance: ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE
Active strength: 50 mg/1; mg/1; mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-726		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-726	21695-726-30	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-726	21695-726-45	I	Inactivated by FDA	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 2 · 66 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	21695-726-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-726-30	`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	21695-726-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-726-30	`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	21695-726-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-726-30	`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	21695-726-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-726-30	`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	21695-726-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-726-30	`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	21695-726-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-726-30	`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	21695-726-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-726-30	`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	21695-726-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-726-30	`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	21695-726-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-726-30	`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	21695-726-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-726-30	`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	21695-726-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-726-30	`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	21695-726-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-726-30	`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	21695-726-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-726-30	`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	21695-726-45	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-726-30	`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	21695-726-45	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-726-30	`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	21695-726-45	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-726-30	`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	21695-726-45	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-726-30	`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	21695-726-45	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-726-30	`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	21695-726-45	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-726-30	`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	21695-726-45	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-726-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31
A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31

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 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	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL			1996-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074654-001	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	385MG;30MG;25MG	TABLET / ORAL			1996-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074654-002	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	770MG;60MG;50MG	TABLET / ORAL	AB	RS	1996-12-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074654-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074654-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074654-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074654-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-726-30	2019-09-24	C162847	48780-1	934fe258-4a49-48b1-e053-8cdaa90a720a	Orphenadrine Citrate, Aspirin and Caffeine Tablets
21695-726-45	2019-09-24	C162847	48780-1	934fe258-4a49-48b1-e053-8cdaa90a720a	Orphenadrine Citrate, Aspirin and Caffeine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-726-30	Orphenadrine Citrate, Aspirin and Caffeine	30 in 1 BOTTLE	TABLET, MULTILAYER	30		1
21695-726-45	Orphenadrine Citrate, Aspirin and Caffeine	45 in 1 BOTTLE	TABLET, MULTILAYER	45		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-726-30	EA - Each	21695-726	c8b05896-1dc2-4276-b0e2-7ce72cfeeaef	1	2012-07-24
21695-726-45	EA - Each	21695-726	aae3a7b1-8576-4c02-9493-d61459d4dbf1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-726	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET, MULTILAYER [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20101124_8e41b33e-f71f-4a5e-b88f-cdfefb2bee20.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
994535	orphenadrine citrate 50 MG / aspirin 770 MG / caffeine 60 MG Oral Tablet	PSN	8e41b33e-f71f-4a5e-b88f-cdfefb2bee20	1
994535	aspirin 770 MG / caffeine 60 MG / orphenadrine citrate 50 MG Oral Tablet	SCD	8e41b33e-f71f-4a5e-b88f-cdfefb2bee20	1
994535	ASA 770 MG / caffeine 60 MG / orphenadrine citrate 50 MG Oral Tablet	SY	8e41b33e-f71f-4a5e-b88f-cdfefb2bee20	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-726-30	21695072630	30 in 1 BOTTLE	Historical
21695-726-45	21695072645	45 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate, Aspirin and Caffeine Tablets	Rebel Distributors Corp	2010-10-22	HUMAN PRESCRIPTION DRUG LABEL	1