FDA.reportPublic FDA data

NDC 46672-648-55 - oxycodone hydrochloride and acetaminophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
46672-648
Requested NDC
46672-648-55
Package NDCs from labels
46672-648-55, 46672-648-04
Manufacturer
Mikart, LLC
Effective date
2020-09-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
oxycodone hydrochloride and acetaminophen - Mikart, LLCMikart, LLC2020-09-24HUMAN PRESCRIPTION DRUG LABEL

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 110 of 189 · 3,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
unii: 362O9ITL9D
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
unii: 362O9ITL9D
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: XF417D3PSL
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCf5ea858e-76d9-4777-b3dc-5d614f66d4852025-04-21WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.71c7a627-6ed9-4f49-8cdc-b3228c021e642025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
unii: C1ENJ2TE6C
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC23780dab-91d8-434f-9342-f5f1ba0a3c0a2025-04-15WarningsExact identifier
unii: 362O9ITL9D
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
unii: 362O9ITL9D
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAurolife Pharma, LLCf9fde75d-7def-48fc-a2b0-727f677f60012025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
unii: 362O9ITL9D
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3242025-04-10WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.92614a3a-331d-16ad-e053-2a95a90a47cc2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm drug1535f903-8bd0-c09e-e063-6294a90a4d4d2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and CodeineACETAMINOPHEN AND CODEINERedPharm Drug, Inc.a35b4ba3-43c0-73c8-e053-2a95a90af5b52025-04-09Boxed warning, WarningsExact identifier
unii: 362O9ITL9D
Oxycodone HCLOXYCODONE HCLDirect_Rx32323565-5add-96a9-e063-6294a90a5b4e2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
Foster and Thrive Pain RelieverACETAMINOPHENStrategic Sourcing Services LLC0a7d82f8-7615-4cef-b245-94b186f3c8fa2025-04-07WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENDirect_Rxe4e27022-581e-ba8c-e053-2a95a90a1ae42025-04-07Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

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