FDA.reportPublic FDA data

NDC 68084-710-11 - Oxycodone 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
68084-710
Requested NDC
68084-710-11
Package NDCs from labels
68084-710-11, 68084-710-01
Manufacturer
American Health Packaging
Effective date
2024-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxycodone and Acetaminophen - American Health PackagingAmerican Health Packaging2024-07-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-710-01Oxycodone and Acetaminophen100 in 1 BOX, UNIT-DOSETABLET1008
68084-710-11Oxycodone and Acetaminophen1 in 1 BLISTER PACKTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-710OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240713_03c9ff0d-46e8-448c-944a-7ad59d1afd6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-710-01EA - Each68084-7107daaf6ea-55f1-4da3-a7a2-803a3f42d39912014-08-01
68084-710-11EA - Each68084-710f911a0ad-37bf-414e-9ff4-9db1fd8d900312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]1

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 94 of 159 · 3,172 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
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
rxcui: 1049225
rxcui: 1049214
rxcui: 1049221
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
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
rxcui: 1049225
unii: 362O9ITL9D
unii: C1ENJ2TE6C
Oxycodone HCLOXYCODONE HCLDirect_Rx323148b2-809a-db11-e063-6294a90abe362025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
AcetaminophenACETAMINOPHENGland Pharma Limiteddb5d4cf8-762a-4111-971e-91c704bc36432025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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