Acetaminophen And Codeine

Product NDC
52959-003
11-digit product format
529590003
Labeler code
52959
Product ID
52959-003_75c9fa2e-a170-69f7-e053-2a91aa0ad11a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA089805
Marketing category
ANDA
Marketing start
1988-09-30
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength
30 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 · 23 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-003IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-00IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-02IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-04IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-06IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-10IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-12IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-14IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-15IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-16IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-20IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-24IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-25IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-28IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-30IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-40IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-42IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-45IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-50IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-60IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-75IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-84IInactivated by FDA2026-08-03
excluded packagepackage52959-00352959-003-90IInactivated by FDA2026-08-03

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 9 · 483 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-84d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-003-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-84f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-003-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-842ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-003-122ef7874e63bc…57b86245f4fa…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089805-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1988-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089805-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-09-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089805-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089805-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089805-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089805-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089805-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089805-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089805-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089805-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089805-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089805-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089805-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089805-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089805-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089805-001AA18072bd15b7f6…
2019-12-13 00:20 UTC2019-12A089805-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089805-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A089805-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089805-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089805-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089805-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089805-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089805-001AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089805-001AA1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-003-30Theracodeine-30030 in 1 BOTTLETABLET30300 mg7
52959-003-00Acetaminophen And Codeine100 in 1 BOTTLE, PLASTICTABLET1004
52959-003-02Acetaminophen And Codeine120 in 1 BOTTLE, PLASTICTABLET1204
52959-003-04Acetaminophen And Codeine4 in 1 BOTTLE, PLASTICTABLET44
52959-003-06Acetaminophen And Codeine6 in 1 BOTTLE, PLASTICTABLET64
52959-003-10Acetaminophen And Codeine10 in 1 BOTTLE, PLASTICTABLET104
52959-003-12Acetaminophen And Codeine12 in 1 BOTTLE, PLASTICTABLET124
52959-003-14Acetaminophen And Codeine14 in 1 BOTTLE, PLASTICTABLET144
52959-003-15Acetaminophen And Codeine15 in 1 BOTTLE, PLASTICTABLET154
52959-003-16Acetaminophen And Codeine16 in 1 BOTTLE, PLASTICTABLET164
52959-003-20Acetaminophen And Codeine20 in 1 BOTTLE, PLASTICTABLET204
52959-003-24Acetaminophen And Codeine24 in 1 BOTTLE, PLASTICTABLET244
52959-003-25Acetaminophen And Codeine25 in 1 BOTTLE, PLASTICTABLET254
52959-003-28Acetaminophen And Codeine28 in 1 BOTTLE, PLASTICTABLET284
52959-003-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET304
52959-003-40Acetaminophen And Codeine40 in 1 BOTTLE, PLASTICTABLET404
52959-003-42Acetaminophen And Codeine42 in 1 BOTTLE, PLASTICTABLET424
52959-003-45Acetaminophen And Codeine45 in 1 BOTTLE, PLASTICTABLET454
52959-003-50Acetaminophen And Codeine50 in 1 BOTTLE, PLASTICTABLET504
52959-003-60Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET604
52959-003-75Acetaminophen And Codeine75 in 1 BOTTLE, PLASTICTABLET754
52959-003-84Acetaminophen And Codeine84 in 1 BOTTLE, PLASTICTABLET844
52959-003-90Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-003-00EA - Each52959-003ada5a4c4-e45c-49fa-bb9c-1aaad8033a4812012-07-24
52959-003-02EA - Each52959-003a536e861-6c70-4b2d-9c08-a0c061ba9e5e12012-07-24
52959-003-04EA - Each52959-003ac05af12-60c7-4604-b371-bfcef0f8452f12012-07-24
52959-003-06EA - Each52959-003cc12f052-0315-449c-a3e3-c2bf4472df0f12012-07-24
52959-003-10EA - Each52959-003caf69ab3-72e8-4030-bbd6-1c9cb2609c3f12012-07-24
52959-003-12EA - Each52959-00373804a8e-5ae2-49f6-b280-6d2ec144cbcf12012-07-24
52959-003-15EA - Each52959-003317de1bb-290b-45be-8438-04eccd533f8312012-07-24
52959-003-16EA - Each52959-003697f1704-26ec-4a2e-90ee-d74c14aa1a0112012-07-24
52959-003-20EA - Each52959-0039ae2460b-2ee9-46df-9b2d-9b1b9a135a8412012-07-24
52959-003-24EA - Each52959-0038f60e8b9-5614-4296-8215-83e6580b1a7d12012-07-24
52959-003-25EA - Each52959-003d7c3e31b-1681-4f6e-8be2-8cfa0e9cf6e312012-07-24
52959-003-28EA - Each52959-003114d7b3a-c288-4410-9b20-23b75d9f6f4512012-07-24
52959-003-30EA - Each52959-003fced24bc-42ac-4210-961d-a118338be5cd12018-10-11
52959-003-40EA - Each52959-003d12f4f2c-02a6-461d-8659-ac7893de386212018-10-11
52959-003-42EA - Each52959-00370a9d8c8-7ed0-427d-902a-e9fe57733f0512018-10-11
52959-003-45EA - Each52959-00397f3f3b9-ea6f-4f32-aadc-862c41ee999312018-10-11
52959-003-50EA - Each52959-0031e9c0c49-fcda-4dca-b565-0d8bc5c189b312018-10-11
52959-003-60EA - Each52959-00322f1dbee-755d-4af2-bae2-0c9c213e5dce12018-10-11
52959-003-75EA - Each52959-0039e581103-7bd7-4d5d-a215-6d59413ee77112018-10-11
52959-003-84EA - Each52959-003b43ffdd0-b38c-4a10-9dd4-24ae5bcda50912018-10-11
52959-003-90EA - Each52959-00307f61a75-c178-4d17-b23d-5dbe59dd4e1012018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
CODEINEACTIVE MOIETYQ830PW7520THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
GELATININACTIVE INGREDIENT2G86QN327LTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTHERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-003THERACODEINE-300 (ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7Legacy NDC20110815_a2ca6210-578d-496c-9a0e-6eb716f87ae6.zip
52959-003ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 22 package rows20180915_97b0ee29-d08e-4d9b-82ed-3ce287dbec28.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEST. MARY'S MEDICAL PARK PHARMACY48eb36ee-e9dc-a719-e063-6394a90aa85e2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack68f4227b-5010-4996-8f8f-024aa546dee62025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.40d4a71e-341e-48b3-b925-ba35b7910dff2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC36988ba2-cefd-99f8-e063-6294a90aa41a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.31d24067-3c25-0f1a-e063-6394a90a9f1d2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP5d9123f6-b322-4fa0-bf48-6335a6adcbb82025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEStrides Pharma Science Limitedc459ed02-afd6-4533-82b6-bfb2c7ab0e722024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089805
application number: ANDA089805

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNa2ca6210-578d-496c-9a0e-6eb716f87ae67
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDa2ca6210-578d-496c-9a0e-6eb716f87ae67
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYa2ca6210-578d-496c-9a0e-6eb716f87ae67
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY97b0ee29-d08e-4d9b-82ed-3ce287dbec284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-003-0052959000300100 in 1 BOTTLE, PLASTICHistorical
52959-003-0252959000302120 in 1 BOTTLE, PLASTICHistorical
52959-003-04529590003044 in 1 BOTTLE, PLASTICHistorical
52959-003-06529590003066 in 1 BOTTLE, PLASTICHistorical
52959-003-105295900031010 in 1 BOTTLE, PLASTICHistorical
52959-003-125295900031212 in 1 BOTTLE, PLASTICHistorical
52959-003-145295900031414 in 1 BOTTLE, PLASTICHistorical
52959-003-155295900031515 in 1 BOTTLE, PLASTICHistorical
52959-003-165295900031616 in 1 BOTTLE, PLASTICHistorical
52959-003-205295900032020 in 1 BOTTLE, PLASTICHistorical
52959-003-245295900032424 in 1 BOTTLE, PLASTICHistorical
52959-003-255295900032525 in 1 BOTTLE, PLASTICHistorical
52959-003-285295900032828 in 1 BOTTLE, PLASTICHistorical
52959-003-305295900033030 in 1 BOTTLEHistorical
52959-003-405295900034040 in 1 BOTTLE, PLASTICHistorical
52959-003-425295900034242 in 1 BOTTLE, PLASTICHistorical
52959-003-455295900034545 in 1 BOTTLE, PLASTICHistorical
52959-003-505295900035050 in 1 BOTTLE, PLASTICHistorical
52959-003-605295900036060 in 1 BOTTLE, PLASTICHistorical
52959-003-755295900037575 in 1 BOTTLE, PLASTICHistorical
52959-003-845295900038484 in 1 BOTTLE, PLASTICHistorical
52959-003-905295900039090 in 1 BOTTLE, PLASTICHistorical