Acetaminophen and Codeine Phosphate

Product NDC: 63187-291
11-digit product format: 631870291
Labeler code: 63187
Product ID: 63187-291_4a2943a5-d06e-489a-9d56-682712ca8a7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form: SOLUTION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA087508
Marketing category: ANDA
Marketing start: 1981-08-21
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-291		D	Discontinued by firm		2026-08-07
excluded package	package	63187-291	63187-291-04	D	Discontinued by firm		2026-08-07

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
A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982

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	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087508-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087508-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087508-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087508-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087508-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087508-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087508-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087508-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087508-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087508-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087508-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087508-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087508-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087508-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087508-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087508-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087508-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087508-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087508-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087508-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087508-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087508-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087508-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087508-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087508-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087508-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087508-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087508-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087508-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087508-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087508-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087508-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087508-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087508-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087508-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087508-001	AA	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-291	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	3	Legacy NDC	20210116_b14edc3f-4490-4ad1-ad72-185b627a033c.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Genus Lifesciences Inc.	95a5d638-3072-4c37-a4cd-f8550328e2c6	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087508 application number: ANDA087508
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	95ac6875-6b14-4cde-8efb-80704e39b8d8	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087508 application number: ANDA087508

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-291-04	63187029104	118 mL in 1 BOTTLE (63187-291-04)	118 ml	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Oral Solution USP CV	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3