ACETAMINOPHEN AND CODEINE

Product NDC: 61919-484
11-digit product format: 619190484
Labeler code: 61919
Product ID: 61919-484_2e805755-8d3f-0e94-e063-6294a90a7bc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN AND CODEINE
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA040419
Marketing category: ANDA
Marketing start: 2019-07-12
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300; 30 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-484		D	Discontinued by firm	2026-10-12
excluded product	product	61919-484		I	Inactivated by FDA	2026-10-12
excluded package	package	61919-484	61919-484-30	D	Discontinued by firm	2026-10-12
excluded package	package	61919-484	61919-484-60	I	Inactivated by FDA	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 92 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
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	61919-484-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-484-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	61919-484-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-484-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-484-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-484-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-484-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-484-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-484-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-484-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-484-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-484-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-484-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-484-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-484-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-484-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-484-71	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-484-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-484-18	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-484-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-484-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-484-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-484-71	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-484-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-484-18	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-484-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-484-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-484-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-484-71	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-484-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-484-18	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-484-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31
A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31
A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040419-001	AA
A040419-002	AA
A040419-003	AA

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040419-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040419-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040419-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040419-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040419-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040419-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040419-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040419-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040419-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040419-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040419-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040419-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040419-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040419-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040419-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040419-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040419-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040419-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040419-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040419-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040419-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040419-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040419-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040419-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040419-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040419-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040419-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040419-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040419-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040419-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040419-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040419-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-001	AA	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ACETAMINOPHEN AND CODEINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	300 mg/1
CODEINE PHOSPHATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
GSL05Y1MN6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993781	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	Available on FDA.report

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, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-484-90	2025-05-02	f386c649-d2ca-0266-e053-dadaa90a7c1a	ACETAMINOPHEN AND CODEINE
61919-484-18	2025-02-19	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-30	2025-02-19	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-71	2025-02-19	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-18	2025-01-30	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-30	2025-01-30	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-71	2025-01-30	2cef2736-7133-d83d-e063-dadaa90ab31f	ACETAMINOPHEN AND CODEINE
61919-484-60	2023-01-30	f386c64a-071c-0266-e053-dadaa90a7c1a	ACETAMINOPHEN AND CODEINE
61919-484-90	2023-01-30	f386c649-d2ca-0266-e053-dadaa90a7c1a	ACETAMINOPHEN AND CODEINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-484-10	ACETAMINOPHEN AND CODEINE	10 in 1 BOTTLE	TABLET	10	7
61919-484-18	ACETAMINOPHEN AND CODEINE	18 in 1 BOTTLE	TABLET	18	7
61919-484-30	ACETAMINOPHEN AND CODEINE	30 in 1 BOTTLE	TABLET	30	7
61919-484-71	ACETAMINOPHEN AND CODEINE	100 in 1 BOTTLE	TABLET	100	7
61919-484-90	ACETAMINOPHEN AND CODEINE	90 in 1 BOTTLE	TABLET	90	2
61919-484-60	ACETAMINOPHEN AND CODEINE	60 in 1 BOTTLE	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-484-10	EA - Each	61919-484	4e04b85e-b29d-4a30-8967-fb12e9bc2836	1	2025-03-04
61919-484-18	EA - Each	61919-484	05e44a6d-6078-4063-beb2-b46845cb50ca	1	2022-04-06
61919-484-30	EA - Each	61919-484	d5e7df74-5477-4461-8b53-179c459d6ea9	1	2018-04-19
61919-484-90	EA - Each	61919-484	db5da418-31b0-4e4a-9b1b-418ae2082850	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-484	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	7	Current NDC, Legacy NDC, 4 package rows	20250221_8d7d6fa4-cc9f-6b4b-e053-2995a90a7286.zip
61919-484	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20250504_8d7ca633-4448-3507-e053-2a95a90a1287.zip
61919-484	ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190713_8d7ca347-ad91-0ae1-e053-2995a90ac400.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 2 of 2 · 21 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	Clinical Solutions Wholesale, LLC	331d92ac-7287-47c7-b573-b5e6cd58c981	2024-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419

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
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	7
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	7
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	7
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	8d7ca633-4448-3507-e053-2a95a90a1287	2
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	8d7ca633-4448-3507-e053-2a95a90a1287	2
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	8d7ca633-4448-3507-e053-2a95a90a1287	2
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	8d7ca347-ad91-0ae1-e053-2995a90ac400	1
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	8d7ca347-ad91-0ae1-e053-2995a90ac400	1
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	8d7ca347-ad91-0ae1-e053-2995a90ac400	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-484-10	61919048410	10 TABLET in 1 BOTTLE (61919-484-10)	10 tablet	2019-07-12		No	No	Current
61919-484-18	61919048418	18 TABLET in 1 BOTTLE (61919-484-18)	18 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-30	61919048430	30 TABLET in 1 BOTTLE (61919-484-30)	30 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-60	61919048460	60 TABLET in 1 BOTTLE (61919-484-60)	60 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-71	61919048471	100 TABLET in 1 BOTTLE (61919-484-71)	100 tablet	2019-07-12	0000-00-00	No	No	Current
61919-484-90	61919048490	90 TABLET in 1 BOTTLE (61919-484-90)	90 tablet	2019-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN AND CODEINE	Direct_Rx	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	2
ACETAMINOPHEN AND CODEINE	Direct_Rx	2025-02-19	HUMAN PRESCRIPTION DRUG LABEL	7
ACETAMINOPHEN AND CODEINE	Direct_Rx	2019-07-12	HUMAN PRESCRIPTION DRUG LABEL	1