Acetaminophen and Codeine Phosphate

Product NDC: 50383-079
Requested package NDC: 50383-079-16
11-digit product format: 503830079
Labeler code: 50383
Product ID: 50383-079_5e22117a-9eaf-48b7-aa43-9f365fce4e5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen and Codeine Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA040119
Marketing category: ANDA
Marketing start: 1996-04-26
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 120 mg/5mL; mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50383-079	50383-079-16	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 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL			1996-04-26

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	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		1996-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040119-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	1996-04-26	`f41ea6bd6efb…`

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	A040119-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040119-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040119-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040119-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040119-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040119-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040119-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040119-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040119-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040119-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040119-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040119-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040119-001	AA	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A040119-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040119-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040119-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040119-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040119-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040119-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040119-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040119-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040119-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040119-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040119-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040119-001	AA	1	`cb3db0bc1861…`

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
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-079-16	2024-01-30	C162847	48780-1	1030e364-fbc5-111a-e063-dadaa90a10e2	Acetaminophen and Codeine Phosphate Oral Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50383-079-16	Acetaminophen and Codeine Phosphate	473 mL in 1 BOTTLE	SOLUTION	473		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-079-05	ML - Milliliter	50383-079	971c890a-bd5d-4f15-96c6-11d7af4210db	1	2015-04-03
50383-079-06	ML - Milliliter	50383-079	e7963854-59d3-4486-a33f-7c76002947f7	1	2015-04-03
50383-079-12	ML - Milliliter	50383-079	2c0778bf-105b-4597-9403-deaf4e1b0be9	1	2015-04-03
50383-079-13	ML - Milliliter	50383-079	1aed6a10-37f5-402f-88ef-ba23fab8af92	1	2015-04-03
50383-079-16	ML - Milliliter	50383-079	647d52d0-a2a3-457a-bd92-c6ba5a21bc58	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [HI-TECH PHARMACAL CO., INC.]	15
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC.]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [APOTHECA, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REDPHARM DRUG INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-079	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AKORN]	34	Legacy NDC, 1 package rows	20221123_83a536d8-385d-46ed-9cd2-47b7efe96ccf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	83a536d8-385d-46ed-9cd2-47b7efe96ccf	34
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	83a536d8-385d-46ed-9cd2-47b7efe96ccf	34
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	83a536d8-385d-46ed-9cd2-47b7efe96ccf	34
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	83a536d8-385d-46ed-9cd2-47b7efe96ccf	34
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	83a536d8-385d-46ed-9cd2-47b7efe96ccf	34
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	83a536d8-385d-46ed-9cd2-47b7efe96ccf	34
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	ccfaceb3-b3d3-4400-bae8-83e2ee272021	21
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	ccfaceb3-b3d3-4400-bae8-83e2ee272021	21
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	ccfaceb3-b3d3-4400-bae8-83e2ee272021	21
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	ccfaceb3-b3d3-4400-bae8-83e2ee272021	21
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	ccfaceb3-b3d3-4400-bae8-83e2ee272021	21
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	ccfaceb3-b3d3-4400-bae8-83e2ee272021	21
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	aa4ad524-fca4-40c7-b7e2-31772e6d4839	6
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	aa4ad524-fca4-40c7-b7e2-31772e6d4839	6
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	aa4ad524-fca4-40c7-b7e2-31772e6d4839	6
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	aa4ad524-fca4-40c7-b7e2-31772e6d4839	6
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	aa4ad524-fca4-40c7-b7e2-31772e6d4839	6
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	aa4ad524-fca4-40c7-b7e2-31772e6d4839	6
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	e1054498-5490-4f3d-8099-bb1183bba946	1
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	7ed43443-45fc-4e72-b3be-6503b4c1c637	1
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	e1054498-5490-4f3d-8099-bb1183bba946	1
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	7ed43443-45fc-4e72-b3be-6503b4c1c637	1
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	7ed43443-45fc-4e72-b3be-6503b4c1c637	1
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	e1054498-5490-4f3d-8099-bb1183bba946	1
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	7ed43443-45fc-4e72-b3be-6503b4c1c637	1
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	e1054498-5490-4f3d-8099-bb1183bba946	1
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	7ed43443-45fc-4e72-b3be-6503b4c1c637	1
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	e1054498-5490-4f3d-8099-bb1183bba946	1
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	e1054498-5490-4f3d-8099-bb1183bba946	1
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	7ed43443-45fc-4e72-b3be-6503b4c1c637	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-079-16	50383007916	473 mL in 1 BOTTLE (50383-079-16)	473 ml	1996-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Oral Solution, USP	Akorn \| Akorn Operating Company LLC	2022-11-15	HUMAN PRESCRIPTION DRUG LABEL	34
Acetaminophen and Codeine Phosphate Oral Solution, USP 120 mg/12 mg per 5 mL	ATLANTIC BIOLOGICALS COPR.	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	6
Acetaminophen and Codeine Phosphate Oral Solution, USP 120 mg/12 mg per 5 mL	Aidarex Pharmaceuticals LLC	2017-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
Acetaminophen and Codeine Phosphate Oral Solution, USP 120 mg/12 mg per 5 mL	Apotheca Inc.	2016-01-19	HUMAN PRESCRIPTION DRUG LABEL	21
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP	RedPharm Drug Inc. \| Hi-Tech Pharmacal Co., Inc.	2011-06-10	HUMAN PRESCRIPTION DRUG LABEL	1