FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
49999-060
11-digit product format
499990060
Labeler code
49999
Product ID
49999-060_37157014-6986-482f-98f7-a397de723db1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-09-14
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
2023-12-31
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 · 13 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49999-060DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-00DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-01DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-06DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-10DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-12DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-15DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-20DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-24DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-30DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-50DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-60DDiscontinued by firm2026-10-12
excluded packagepackage49999-06049999-060-90DDiscontinued by firm2026-10-12

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 · 117 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549999-060-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549999-060-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649999-060-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149999-060-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849999-060-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149999-060-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049999-060-12cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31
A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31
A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3184e616aacf4f…
2026-08-18 06:07:402026-07A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31301d65b070ca…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040419-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A040419-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A040419-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A040419-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040419-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040419-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040419-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040419-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040419-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-001AA1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
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c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
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b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49999-060-00ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET1003394
49999-060-01ACETAMINOPHEN AND CODEINE PHOSPHATE120 in 1 BOTTLETABLET1203394
49999-060-06ACETAMINOPHEN AND CODEINE PHOSPHATE6 in 1 BOTTLETABLET63394
49999-060-10ACETAMINOPHEN AND CODEINE PHOSPHATE10 in 1 BOTTLETABLET103394
49999-060-12ACETAMINOPHEN AND CODEINE PHOSPHATE12 in 1 BOTTLETABLET123394
49999-060-15ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET153394
49999-060-20ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET203394
49999-060-24ACETAMINOPHEN AND CODEINE PHOSPHATE24 in 1 BOTTLETABLET243394
49999-060-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET303394
49999-060-50ACETAMINOPHEN AND CODEINE PHOSPHATE50 in 1 BOTTLETABLET503394
49999-060-60ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET603394
49999-060-90ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET903394

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-060-00EA - Each49999-060644d3396-2256-4f6a-9816-0538ecad0b0712012-07-24
49999-060-01EA - Each49999-060ee17e178-d93b-4659-ba96-e1e17931071d12012-07-24
49999-060-06EA - Each49999-060bccd3832-f680-44fc-b1ae-1a9e5461728812016-10-06
49999-060-10EA - Each49999-060c682267f-34bb-4d44-b0fd-520e3460a91512012-07-24
49999-060-12EA - Each49999-0605a0fd925-5215-46de-95b0-5e91f7019b7512012-07-24
49999-060-15EA - Each49999-060ac2dc670-53cc-4f7d-9c99-cf7f84b6537e12012-07-24
49999-060-20EA - Each49999-0602dace301-1c34-4a0c-81cb-ab6edbc3dd3712012-07-24
49999-060-24EA - Each49999-06063b1a7c4-386f-4b3d-bf30-c13e7dd5a5e212016-10-06
49999-060-30EA - Each49999-0606681467b-cb54-4374-8e3c-63faf1621b6812012-07-24
49999-060-50EA - Each49999-06009cd9a13-faec-4095-87ed-7721d99acbba12012-07-24
49999-060-60EA - Each49999-060cd5834ca-d490-4e58-8cc6-f9a294bae6b612012-07-24
49999-060-90EA - Each49999-06008aaea21-1e91-4bf1-be49-453084a1a70912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [QUALITY CARE PRODUCTS, LLC]3394Legacy NDC, 12 package rows20241218_3b455938-7bbc-4626-939b-40b37709befb.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEClinical Solutions Wholesale, LLC331d92ac-7287-47c7-b573-b5e6cd58c9812024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN3b455938-7bbc-4626-939b-40b37709befb3394
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD3b455938-7bbc-4626-939b-40b37709befb3394
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY3b455938-7bbc-4626-939b-40b37709befb3394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-060-0049999006000100 TABLET in 1 BOTTLE (49999-060-00) 100 tablet2011-09-140000-00-00NoNoCurrent
49999-060-0149999006001120 TABLET in 1 BOTTLE (49999-060-01) 120 tablet2011-09-140000-00-00NoNoCurrent
49999-060-06499990060066 in 1 BOTTLEHistorical
49999-060-104999900601010 in 1 BOTTLEHistorical
49999-060-124999900601212 in 1 BOTTLEHistorical
49999-060-154999900601515 in 1 BOTTLEHistorical
49999-060-204999900602020 TABLET in 1 BOTTLE (49999-060-20) 20 tablet2011-09-140000-00-00NoNoCurrent
49999-060-244999900602424 TABLET in 1 BOTTLE (49999-060-24) 24 tablet2011-09-140000-00-00NoNoCurrent
49999-060-304999900603030 TABLET in 1 BOTTLE (49999-060-30) 30 tablet2011-09-140000-00-00NoNoCurrent
49999-060-504999900605050 TABLET in 1 BOTTLE (49999-060-50) 50 tablet2011-09-140000-00-00NoNoCurrent
49999-060-604999900606060 TABLET in 1 BOTTLE (49999-060-60) 60 tablet2011-09-140000-00-00NoNoCurrent
49999-060-904999900609090 TABLET in 1 BOTTLE (49999-060-90) 90 tablet2011-09-140000-00-00NoNoCurrent