Acetaminophen and Codeine Phosphate

Product NDC: 0121-0504
11-digit product format: 001210504
Labeler code: 0121
Product ID: 0121-0504_850320f4-13d8-38c7-e053-2991aa0a4947
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
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: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0121-0504		D	Discontinued by firm	2026-08-03
excluded package	package	0121-0504	0121-0504-04	D	Discontinued by firm	2026-08-03
excluded package	package	0121-0504	0121-0504-05	D	Discontinued by firm	2026-08-03
excluded package	package	0121-0504	0121-0504-16	D	Discontinued by firm	2026-08-03
excluded package	package	0121-0504	0121-0504-40	D	Discontinued by firm	2026-08-03

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 · 31 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-0504-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-0504-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-0504-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-0504-40	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0121-0504-16	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0121-0504-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0121-0504-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0121-0504-40	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0121-0504-16	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0121-0504-12	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0121-0504-04	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0121-0504-16	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0121-0504-00	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0121-0504-12	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0121-0504-04	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0121-0504-16	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0121-0504-00	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0121-0504-12	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0121-0504-04	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0121-0504-16	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0121-0504-00	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0121-0504-12	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0121-0504-04	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0121-0504-16	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0121-0504-00	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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 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, Related label table
NDC	Related label
0121-0504-00	Acetaminophen and Codeine Phosphate Oral Solution USP CV
0121-0504-04	Acetaminophen and Codeine Phosphate Oral Solution USP CV
0121-0504-12	Acetaminophen and Codeine Phosphate Oral Solution USP CV
0121-0504-16	Acetaminophen and Codeine Phosphate Oral Solution USP CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-0504-04	Acetaminophen and Codeine Phosphate	118 mL in 1 BOTTLE	SOLUTION	118	31
0121-0504-05	Acetaminophen and Codeine Phosphate	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	31
0121-0504-16	Acetaminophen and Codeine Phosphate	473 mL in 1 BOTTLE	SOLUTION	473	31
0121-0504-40	Acetaminophen and Codeine Phosphate	40 in 1 CASE	SOLUTION	40	31
0121-0504-40	Acetaminophen and Codeine Phosphate	10 in 1 TRAY	SOLUTION	10	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0504-00	ML - Milliliter	0121-0504	d7a3f004-ca0c-4f1c-ad5c-6c46275f59eb	1	2017-08-11
0121-0504-04	ML - Milliliter	0121-0504	969a676e-4598-4cc4-aa2f-60d6e59bcbed	1	2012-07-24
0121-0504-05	ML - Milliliter	0121-0504	eea7e525-e9ad-4b1e-878d-c5d4bfef77c1	1	2012-07-24
0121-0504-10	ML - Milliliter	0121-0504	b2ee4dd9-3150-43a2-a695-2814f460eb5c	1	2012-07-24
0121-0504-12	ML - Milliliter	0121-0504	53d82ab1-3ee7-4a3e-81ef-6cf19e25837e	1	2012-07-24
0121-0504-15	ML - Milliliter	0121-0504	3fdc83aa-2edd-43ae-a741-d9a7b3f0187f	1	2012-07-24
0121-0504-16	ML - Milliliter	0121-0504	0d39973b-5f07-4967-a63b-610e51a8c866	1	2012-07-24
0121-0504-40	ML - Milliliter	0121-0504	d1ba4a38-dc9d-4a05-b7f2-983aa8550c19	1	2024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	3
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	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
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0504	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	31	Legacy NDC, 5 package rows	20241006_95ac6875-6b14-4cde-8efb-80704e39b8d8.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 ndc (product): 0121-0504

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	95ac6875-6b14-4cde-8efb-80704e39b8d8	31
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	95ac6875-6b14-4cde-8efb-80704e39b8d8	31
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	95ac6875-6b14-4cde-8efb-80704e39b8d8	31
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	95ac6875-6b14-4cde-8efb-80704e39b8d8	31
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	95ac6875-6b14-4cde-8efb-80704e39b8d8	31
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	95ac6875-6b14-4cde-8efb-80704e39b8d8	31
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	f522eae6-383a-45e9-a077-37780db6b14d	5
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	f522eae6-383a-45e9-a077-37780db6b14d	5
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	f522eae6-383a-45e9-a077-37780db6b14d	5
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	f522eae6-383a-45e9-a077-37780db6b14d	5
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	f522eae6-383a-45e9-a077-37780db6b14d	5
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	f522eae6-383a-45e9-a077-37780db6b14d	5
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	616fdb50-ee82-2a80-e053-2991aa0a1a94	4
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	616fdb50-ee82-2a80-e053-2991aa0a1a94	4
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	616fdb50-ee82-2a80-e053-2991aa0a1a94	4
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	616fdb50-ee82-2a80-e053-2991aa0a1a94	4
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	616fdb50-ee82-2a80-e053-2991aa0a1a94	4
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	616fdb50-ee82-2a80-e053-2991aa0a1a94	4
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	59c33fd9-ef24-4893-b904-3e5f8cea58c7	3
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	59c33fd9-ef24-4893-b904-3e5f8cea58c7	3
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	59c33fd9-ef24-4893-b904-3e5f8cea58c7	3
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	59c33fd9-ef24-4893-b904-3e5f8cea58c7	3
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	59c33fd9-ef24-4893-b904-3e5f8cea58c7	3
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	59c33fd9-ef24-4893-b904-3e5f8cea58c7	3
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	f45ed4dd-6fcf-1de6-e053-2995a90a8c2d	2
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	f45ed4dd-6fcf-1de6-e053-2995a90a8c2d	2
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	f45ed4dd-6fcf-1de6-e053-2995a90a8c2d	2
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	f45ed4dd-6fcf-1de6-e053-2995a90a8c2d	2
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	f45ed4dd-6fcf-1de6-e053-2995a90a8c2d	2
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	f45ed4dd-6fcf-1de6-e053-2995a90a8c2d	2
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	9bf3c04c-22d8-493f-8dbd-c10613042ee5	1
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	9bf3c04c-22d8-493f-8dbd-c10613042ee5	1
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	9bf3c04c-22d8-493f-8dbd-c10613042ee5	1
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	9bf3c04c-22d8-493f-8dbd-c10613042ee5	1
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	9bf3c04c-22d8-493f-8dbd-c10613042ee5	1
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	9bf3c04c-22d8-493f-8dbd-c10613042ee5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0121-0504-04	00121050404	118 mL in 1 BOTTLE	118 ml	Historical
0121-0504-05	00121050405	5 mL in 1 CUP, UNIT-DOSE	5 ml	Historical
0121-0504-16	00121050416	473 mL in 1 BOTTLE	473 ml	Historical
0121-0504-40	00121050440	40 in 1 CASE		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Oral Solution USP CV	A-S Medication Solutions	2025-01-06	HUMAN PRESCRIPTION DRUG LABEL	26
Acetaminophen and Codeine Phosphate Oral Solution USP CV	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	31
Acetaminophen and Codeine Phosphate Oral Solution USP CV	Redpharm Drug, Inc	2024-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
Acetaminophen and Codeine Phosphate Oral Solution USP CV	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Acetaminophen and Codeine Phosphate Oral Solution USP CV	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Acetaminophen and Codeine Phosphate Oral Solution USP CV	NuCare Pharmaceuticals,Inc.	2020-03-31	HUMAN PRESCRIPTION DRUG LABEL	4
Acetaminophen and Codeine Phosphate Oral Solution USP CV	Aidarex Pharmaceuticals LLC	2013-11-12	HUMAN PRESCRIPTION DRUG LABEL	3
Acetaminophen and Codeine Phosphate - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-11-10	HUMAN PRESCRIPTION DRUG LABEL	1
Acetaminophen and Codeine Phosphate - STAT RX USA LLC	STAT RX USA LLC	2010-03-15	HUMAN PRESCRIPTION DRUG LABEL	1