Acetaminophen and Codeine Phosphate

Product NDC: 33261-470
11-digit product format: 332610470
Labeler code: 33261
Product ID: 33261-470_86859de8-6f89-477b-8e5a-c9634bb99693
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form: SOLUTION
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
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: 2019-12-31
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	33261-470		I	Inactivated by FDA		2026-08-03
excluded package	package	33261-470	33261-470-01	I	Inactivated by FDA		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 · 42 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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`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	33261-470-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-470-01	`9bebd1f3094a…`	`5416666fcb17…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-470-01	2020-01-31	C162847	48780-1	9d75b9d0-a32a-f424-e053-dadaa90a57ce	Acetaminophen and Codeine Phosphate Oral Solution USP CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-470-01	Acetaminophen and Codeine Phosphate	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-470-01	ML - Milliliter	33261-470	8b4e6ac9-3c73-4a04-acfd-c0031a23f423	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	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
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 [AIDAREX PHARMACEUTICALS LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	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
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-470	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 1 package rows	20140213_59c33fd9-ef24-4893-b904-3e5f8cea58c7.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

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
33261-470-01	33261047001	118 mL in 1 BOTTLE, PLASTIC	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Oral Solution USP CV	Aidarex Pharmaceuticals LLC	2013-11-12	HUMAN PRESCRIPTION DRUG LABEL	3