ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC: 67544-002
Requested package NDC: 67544-002-20
11-digit product format: 675440002
Labeler code: 67544
Product ID: 67544-002_c4cf2f28-c73e-4370-843e-487b7b42e077
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen and codeine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040419
Marketing category: ANDA
Marketing start: 2011-07-06
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-002	67544-002-20	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-002	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	RS	2001-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-003	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	AA	RS	2001-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	AA	RS	2001-05-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040419-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040419-001	AA	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: ACETAMINOPHEN AND CODEINE PHOSPHATE
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
GSL05Y1MN6	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993770	Internal RxNorm lookup
993781	Internal RxNorm lookup
993890	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
d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-002-09	ACETAMINOPHEN AND CODEINE PHOSPHATE	9 in 1 BOTTLE, PLASTIC	TABLET	9	5
67544-002-15	ACETAMINOPHEN AND CODEINE PHOSPHATE	15 in 1 BOTTLE, PLASTIC	TABLET	15	5
67544-002-20	ACETAMINOPHEN AND CODEINE PHOSPHATE	20 in 1 BOTTLE, PLASTIC	TABLET	20	5
67544-002-30	ACETAMINOPHEN AND CODEINE PHOSPHATE	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
67544-002-40	ACETAMINOPHEN AND CODEINE PHOSPHATE	40 in 1 BOTTLE, PLASTIC	TABLET	40	5
67544-002-45	ACETAMINOPHEN AND CODEINE PHOSPHATE	45 in 1 BOTTLE, PLASTIC	TABLET	45	5
67544-002-46	ACETAMINOPHEN AND CODEINE PHOSPHATE	56 in 1 BOTTLE, PLASTIC	TABLET	56	5
67544-002-50	ACETAMINOPHEN AND CODEINE PHOSPHATE	50 in 1 BOTTLE, PLASTIC	TABLET	50	5
67544-002-53	ACETAMINOPHEN AND CODEINE PHOSPHATE	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
67544-002-54	ACETAMINOPHEN AND CODEINE PHOSPHATE	84 in 1 BOTTLE, PLASTIC	TABLET	84	5
67544-002-55	ACETAMINOPHEN AND CODEINE PHOSPHATE	75 in 1 BOTTLE, PLASTIC	TABLET	75	5
67544-002-60	ACETAMINOPHEN AND CODEINE PHOSPHATE	90 in 1 BOTTLE, PLASTIC	TABLET	90	5
67544-002-70	ACETAMINOPHEN AND CODEINE PHOSPHATE	120 in 1 BOTTLE, PLASTIC	TABLET	120	5
67544-002-72	ACETAMINOPHEN AND CODEINE PHOSPHATE	112 in 1 BOTTLE, PLASTIC	TABLET	112	5
67544-002-75	ACETAMINOPHEN AND CODEINE PHOSPHATE	150 in 1 BOTTLE, PLASTIC	TABLET	150	5
67544-002-80	ACETAMINOPHEN AND CODEINE PHOSPHATE	180 in 1 BOTTLE, PLASTIC	TABLET	180	5
67544-002-85	ACETAMINOPHEN AND CODEINE PHOSPHATE	200 in 1 BOTTLE, PLASTIC	TABLET	200	5
67544-002-90	ACETAMINOPHEN AND CODEINE PHOSPHATE	240 in 1 BOTTLE, PLASTIC	TABLET	240	5
67544-002-93	ACETAMINOPHEN AND CODEINE PHOSPHATE	300 in 1 BOTTLE, PLASTIC	TABLET	300	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-002-15	EA - Each	67544-002	96d5967b-4b01-41e6-9757-357495cbb11c	1	2014-06-03
67544-002-20	EA - Each	67544-002	f265494a-6aa8-4cd3-9d65-654f2d7f01d1	1	2014-06-03
67544-002-30	EA - Each	67544-002	fed59c6a-3a03-4a0a-ab3e-f55c3a1e416f	1	2014-06-03
67544-002-40	EA - Each	67544-002	6bde1cc4-50e0-4657-947b-a825f03a72a8	1	2014-06-03
67544-002-45	EA - Each	67544-002	5f9faf07-ae23-44da-b711-4ff7f7f9f997	1	2014-06-03
67544-002-46	EA - Each	67544-002	a8be8bf0-58de-4153-abea-d2f0aa6e3e59	1	2021-09-07
67544-002-50	EA - Each	67544-002	bb092ed9-690f-4857-ad84-61b424b40705	1	2014-06-03
67544-002-53	EA - Each	67544-002	8a31ce77-3667-4383-9d4a-b522eabb5d22	1	2014-06-03
67544-002-54	EA - Each	67544-002	13910e79-e001-4a21-9237-d2562a479d32	1	2021-09-07
67544-002-55	EA - Each	67544-002	dd0e221c-4730-498d-9dc7-bb8f5cfb2d66	1	2014-06-03
67544-002-60	EA - Each	67544-002	be6fd85a-f9a4-4ce1-ab2f-d9dbde147545	1	2014-06-03
67544-002-70	EA - Each	67544-002	2a8ef6d6-2f85-4092-b1da-3893f0153402	1	2014-06-03
67544-002-72	EA - Each	67544-002	208db864-0bae-4f98-a32d-e6414ca6ed08	1	2021-09-07
67544-002-75	EA - Each	67544-002	8d8f2fda-8df1-45b5-ba76-6476c73c700c	1	2014-06-03
67544-002-80	EA - Each	67544-002	2302ea2a-9268-465b-8a41-58cbc9fe438c	1	2014-06-03
67544-002-85	EA - Each	67544-002	fa340a95-fdd6-43cd-8b9c-87bc586103ee	1	2014-06-03
67544-002-90	EA - Each	67544-002	f237aca3-47bb-45bd-a142-12011631121a	1	2014-06-03
67544-002-93	EA - Each	67544-002	cdf94354-1342-4a37-a6fa-7b2ea7c5e8a6	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-002	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	5	Current NDC, Legacy NDC, 19 package rows	20250110_d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1.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 2 · 22 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	SpecGx LLC	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Unit Dose Solutions, Inc.	537245e8-5e2a-c3e0-e063-6394a90ac858	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	St. Mary's Medical Park Pharmacy	eac5f350-93e5-4dc2-e053-2a95a90aed60	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	REMEDYREPACK INC.	5c96d033-bf7c-47de-aa0d-5998b3bf4a63	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	9ca1321e-380a-48d7-8a58-c6501858c1c0	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	dff53120-a609-4720-bd69-2391798c7dee	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	297dc9ff-e34f-434b-b1a4-4c995a5bac8b	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Preferred Pharmaceuticals Inc.	55d494b1-c828-4841-8f64-75b92cd54cb6	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Preferred Pharmaceuticals Inc.	2453d635-989d-4569-96b3-4efaf61cca71	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	a6e9b316-549d-4058-8c08-407e4ce5c255	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE	ACETAMINOPHEN AND CODEINE	Direct_Rx	8d7ca633-4448-3507-e053-2a95a90a1287	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE	ACETAMINOPHEN AND CODEINE	Direct_Rx	8d7d6fa4-cc9f-6b4b-e053-2995a90a7286	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	73e2086e-f513-537f-e053-2991aa0a1348	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Direct_Rx	e78e50c0-36da-528e-e053-2995a90a3d80	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Aphena Pharma Solutions - Tennessee, LLC	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419 ndc (package): 67544-002-20 ndc (product): 67544-002 ndc11 (package): 67544000220
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Quality Care Products, LLC	3b455938-7bbc-4626-939b-40b37709befb	2024-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	3f7737d1-ec78-467e-8903-9cb8eba0ab0b	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	18315a6f-9e89-46d7-81d3-905b8a51aa79	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Proficient Rx LP	a8f8bb34-6d61-47a8-b58b-0b6763458052	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040419 application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	6f2ce909-6356-1c2c-e053-2a91aa0a0135	2024-06-10	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
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-002-20	67544000220	20 TABLET in 1 BOTTLE, PLASTIC (67544-002-20)	20 tablet	2011-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN AND CODEINE PHOSPHATE	Aphena Pharma Solutions - Tennessee, LLC	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	5