FDA.reportPublic FDA data

APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule

RxCUI
889520
RxNorm name
APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
Display name
APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
Full name
APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINESun Pharmaceutical Industries, Inc.a68de112-f5af-49ba-a8a8-3adbaa7df36e2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEActavis Pharma, Inc.ea5b9ffe-3cda-405e-8f75-3fd4a64c9a352025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
FioricetBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEActavis Pharma, Inc.c018be7d-f7b8-45e2-97b8-8e7a717406572025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAvKAREf5bbad36-6a0e-3518-3f12-138ae9f639802025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack03475828-eae2-49ed-a1c0-8074f35c712d2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAdvanced Rx of Tennessee, LLC2e20e0ee-dd73-6287-e063-6294a90a03b12025-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESUNRISE PHARMACEUTICAL, INCee7630f8-f4b8-4eb0-b34d-d908567030c42025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
Butalbital/Acetaminophen/CaffeineBUTALBITAL/ACETAMINOPHEN/CAFFEINEAdvanced Rx Pharmacy of Tennessee, LLCf16429e2-4944-5bbc-e053-2a95a90ab5282024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3fe91e9f-4033-4b48-b51b-7eb67d40fa3a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESOLCO HEALTHCARE US, LLC5c9c3407-212a-4ae9-a574-2b0c53f3c5eb2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC8438f08f-a32a-4180-9030-e0fd5da4be302024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESeton Pharmaceuticals LLC3c5cefe3-c84e-4380-97f3-78e3fe92543a2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGranules Pharmaceuticals Inc.2407efce-b77e-4072-bc4b-62c789d01e1a2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULESLannett Company, Inc.4d62259d-a582-4621-b62e-3d5640cadf7c2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 889520

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 18 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
03475828-eae2-49ed-a1c0-8074f35c712dbutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]3104Butalbital, Acetaminophen and Caffeine Capsules, USP20250321
3fe91e9f-4033-4b48-b51b-7eb67d40fa3abutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]3101Butalbital, Acetaminophen and Caffeine Capsules, USP20241219
4d62259d-a582-4621-b62e-3d5640cadf7cbutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]312Butalbital, Acetaminophen, and Caffeine Capsules, USP Rx only20230714
c018be7d-f7b8-45e2-97b8-8e7a71740657butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]311Fioricet® Capsules20251210
ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]311Butalbital, Acetaminophen, and Caffeine Capsules, USP Rx only20251210
f5bbad36-6a0e-3518-3f12-138ae9f63980butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]310Butalbital, Acetaminophen, and Caffeine Capsules, USP20251111
2407efce-b77e-4072-bc4b-62c789d01e1abutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]36Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg Rx only20231204
ee7630f8-f4b8-4eb0-b34d-d908567030c4butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]35Butalbital, Acetaminophen and Caffeine Capsules, USP20250116
611356c6-9cf6-4316-a9cb-e7756955755bbutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]35Butalbital, Acetaminophen, and Caffeine Capsules Rx only20190906
a68de112-f5af-49ba-a8a8-3adbaa7df36ebutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]34Butalbital, Acetaminophen5234032-0922-00, and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg20240821
8438f08f-a32a-4180-9030-e0fd5da4be30butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]34Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/300mg/ 40 mg CIII RX Only20240507
f16429e2-4944-5bbc-e053-2a95a90ab528butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]33Butalbital/Acetaminophen/Caffeine Capsules20241231
3c5cefe3-c84e-4380-97f3-78e3fe92543abutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]33Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/325 mg/40 mg and 50 mg/300 mg/40 mg20240130
5c9c3407-212a-4ae9-a574-2b0c53f3c5ebbutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]32Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg20240910
2e20e0ee-dd73-6287-e063-6294a90a03b1butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]31Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg20250214
83a63e9b-0a97-4725-bcbb-906fb678ba42butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]31Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg20201001
5f6997ee-45d5-4ef9-a829-a284a35a4e72butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]31Butalbital, Acetaminophen and Caffeine Capsules, USP20170426
d3c69436-a681-4e00-8db0-8cbfaac9627ebutalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule [PSN] · acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SCD] · APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule [SY]31Butalbital, Acetaminophen, and Caffeine Capsules Rx only20100423