FDA.reportPublic FDA data

butalbital 50 MG / acetaminophen 300 MG Oral Tablet

RxCUI
1249617
RxNorm name
butalbital 50 MG / acetaminophen 300 MG Oral Tablet
Display name
butalbital 50 MG / acetaminophen 300 MG Oral Tablet
Full name
butalbital 50 MG / acetaminophen 300 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAmici Pharma, Inc.3280501f-928a-4112-803d-fb9771c865472026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1249617
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAarkish Pharmaceuticals NJ Inc.82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a62025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1249617
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENBurel Pharmaceuticals, LLC0a8a6a16-b23f-45d2-b5d4-540264e74d142024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1249617
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC1f0dbe62-6aea-4323-ad25-c2211f9192532024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1249617
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1249617

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN6Butalbital and Acetaminophen Tablets 50 mg/ 300 mg20250617
82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD6Butalbital and Acetaminophen Tablets 50 mg/ 300 mg20250617
82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6APAP 300 MG / butalbital 50 MG Oral TabletSY6Butalbital and Acetaminophen Tablets 50 mg/ 300 mg20250617
669e3bd0-fbd9-423c-8654-a78fe650e3e2acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD6Butalbital and Acetaminophen Tablets 50 mg/300 mg20190822
669e3bd0-fbd9-423c-8654-a78fe650e3e2butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN6Butalbital and Acetaminophen Tablets 50 mg/300 mg20190822
669e3bd0-fbd9-423c-8654-a78fe650e3e2APAP 300 MG / butalbital 50 MG Oral TabletSY6Butalbital and Acetaminophen Tablets 50 mg/300 mg20190822
1f0dbe62-6aea-4323-ad25-c2211f919253butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN4Butalbital and Acetaminophen Tablets20240506
1f0dbe62-6aea-4323-ad25-c2211f919253acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD4Butalbital and Acetaminophen Tablets20240506
1f0dbe62-6aea-4323-ad25-c2211f919253APAP 300 MG / butalbital 50 MG Oral TabletSY4Butalbital and Acetaminophen Tablets20240506
d2213ffd-18f6-45f5-9af7-690a977562c4acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD4Butalbital and Acetaminophen Tablets 50 mg/300 mg20200402
d2213ffd-18f6-45f5-9af7-690a977562c4APAP 300 MG / butalbital 50 MG Oral TabletSY4Butalbital and Acetaminophen Tablets 50 mg/300 mg20200402
d2213ffd-18f6-45f5-9af7-690a977562c4butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN4Butalbital and Acetaminophen Tablets 50 mg/300 mg20200402
0a8a6a16-b23f-45d2-b5d4-540264e74d14acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD3Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx only20241018
0a8a6a16-b23f-45d2-b5d4-540264e74d14butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN3Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx only20241018
0a8a6a16-b23f-45d2-b5d4-540264e74d14APAP 300 MG / butalbital 50 MG Oral TabletSY3Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx only20241018
3280501f-928a-4112-803d-fb9771c86547APAP 300 MG / butalbital 50 MG Oral TabletSY1Butalbital and Acetaminophen Tablets20260317
3280501f-928a-4112-803d-fb9771c86547acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD1Butalbital and Acetaminophen Tablets20260317
3280501f-928a-4112-803d-fb9771c86547butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN1Butalbital and Acetaminophen Tablets20260317
a24ccca7-e347-44e4-b700-1cc54c525bd3APAP 300 MG / butalbital 50 MG Oral TabletSY1Butalbital and Acetaminophen Tablets 50 mg/300 mg20200813
a24ccca7-e347-44e4-b700-1cc54c525bd3butalbital 50 MG / acetaminophen 300 MG Oral TabletPSN1Butalbital and Acetaminophen Tablets 50 mg/300 mg20200813
a24ccca7-e347-44e4-b700-1cc54c525bd3acetaminophen 300 MG / butalbital 50 MG Oral TabletSCD1Butalbital and Acetaminophen Tablets 50 mg/300 mg20200813