ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC: 12634-526
11-digit product format: 126340526
Labeler code: 12634
Product ID: 12634-526_29b3e671-afb3-2c71-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca, Inc.
Application: ANDA089805
Marketing category: ANDA
Marketing start: 2002-05-03
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIII
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 · 16 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-526		I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-00	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-01	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-40	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-50	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-55	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-59	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-65	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-66	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-71	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-80	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-82	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-85	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-91	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-94	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-526	12634-526-96	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 6 · 336 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	12634-526-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-526-01	`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	12634-526-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-526-01	`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	12634-526-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-65	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-526-01	`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	12634-526-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-66	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-526-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA		1988-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089805-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	AA	1988-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089805-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL		1988-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089805-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089805-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089805-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089805-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089805-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089805-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089805-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089805-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089805-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089805-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089805-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089805-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089805-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089805-001	AA	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A089805-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089805-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089805-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089805-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089805-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089805-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089805-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089805-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089805-001	AA	1	`a50c72e98297…`

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
12634-526-00	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-01	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-40	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-50	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-55	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-59	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-65	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-66	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-71	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-80	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-82	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-85	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-91	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-94	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
12634-526-96	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-526-00	ACETAMINOPHEN AND CODEINE PHOSPHATE	10 in 1 BOTTLE	TABLET	10	8
12634-526-01	ACETAMINOPHEN AND CODEINE PHOSPHATE	100 in 1 BOTTLE	TABLET	100	8
12634-526-40	ACETAMINOPHEN AND CODEINE PHOSPHATE	40 in 1 BOTTLE	TABLET	40	8
12634-526-50	ACETAMINOPHEN AND CODEINE PHOSPHATE	50 in 1 BOTTLE	TABLET	50	8
12634-526-55	ACETAMINOPHEN AND CODEINE PHOSPHATE	15 in 1 BLISTER PACK	TABLET	15	8
12634-526-59	ACETAMINOPHEN AND CODEINE PHOSPHATE	30 in 1 BLISTER PACK	TABLET	30	8
12634-526-65	ACETAMINOPHEN AND CODEINE PHOSPHATE	5 in 1 BLISTER PACK	TABLET	5	8
12634-526-66	ACETAMINOPHEN AND CODEINE PHOSPHATE	6 in 1 BLISTER PACK	TABLET	6	8
12634-526-71	ACETAMINOPHEN AND CODEINE PHOSPHATE	30 in 1 BOTTLE	TABLET	30	8
12634-526-80	ACETAMINOPHEN AND CODEINE PHOSPHATE	20 in 1 BOTTLE	TABLET	20	8
12634-526-82	ACETAMINOPHEN AND CODEINE PHOSPHATE	12 in 1 BOTTLE	TABLET	12	8
12634-526-85	ACETAMINOPHEN AND CODEINE PHOSPHATE	15 in 1 BOTTLE	TABLET	15	8
12634-526-91	ACETAMINOPHEN AND CODEINE PHOSPHATE	1 in 1 BLISTER PACK	TABLET	1	8
12634-526-94	ACETAMINOPHEN AND CODEINE PHOSPHATE	4 in 1 BOTTLE	TABLET	4	8
12634-526-96	ACETAMINOPHEN AND CODEINE PHOSPHATE	6 in 1 BOTTLE	TABLET	6	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12634-526-80	EA - Each	12634-526	0b5c5fea-befd-4f0b-bc86-8912069ff075	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 TABLET [APOTHECA, INC.]	3
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-526	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.]	8	Legacy NDC, 15 package rows	20160120_909b5ad2-c78d-431c-a725-31fe02a2b21d.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 · 7 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	ST. MARY'S MEDICAL PARK PHARMACY	48eb36ee-e9dc-a719-e063-6394a90aa85e	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	68f4227b-5010-4996-8f8f-024aa546dee6	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	REMEDYREPACK INC.	40d4a71e-341e-48b3-b925-ba35b7910dff	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Advanced Rx of Tennessee, LLC	36988ba2-cefd-99f8-e063-6294a90aa41a	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals, Inc.	31d24067-3c25-0f1a-e063-6394a90a9f1d	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Proficient Rx LP	5d9123f6-b322-4fa0-bf48-6335a6adcbb8	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Strides Pharma Science Limited	c459ed02-afd6-4533-82b6-bfb2c7ab0e72	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089805 application number: ANDA089805

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	909b5ad2-c78d-431c-a725-31fe02a2b21d	8
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	909b5ad2-c78d-431c-a725-31fe02a2b21d	8
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	909b5ad2-c78d-431c-a725-31fe02a2b21d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-526-00	12634052600	10 in 1 BOTTLE	Historical
12634-526-01	12634052601	100 in 1 BOTTLE	Historical
12634-526-40	12634052640	40 in 1 BOTTLE	Historical
12634-526-50	12634052650	50 in 1 BOTTLE	Historical
12634-526-55	12634052655	15 in 1 BLISTER PACK	Historical
12634-526-59	12634052659	30 in 1 BLISTER PACK	Historical
12634-526-65	12634052665	5 in 1 BLISTER PACK	Historical
12634-526-66	12634052666	6 in 1 BLISTER PACK	Historical
12634-526-71	12634052671	30 in 1 BOTTLE	Historical
12634-526-80	12634052680	20 in 1 BOTTLE	Historical
12634-526-82	12634052682	12 in 1 BOTTLE	Historical
12634-526-85	12634052685	15 in 1 BOTTLE	Historical
12634-526-91	12634052691	1 in 1 BLISTER PACK	Historical
12634-526-94	12634052694	4 in 1 BOTTLE	Historical
12634-526-96	12634052696	6 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only	Apotheca, Inc. \| Apotheca Inc.	2016-01-19	HUMAN PRESCRIPTION DRUG LABEL	8