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 147 of 158 · 3,148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENWALGREEN CO.cc939a7c-ce56-5dd6-e053-2995a90aa8af2023-12-06WarningsExact identifier
unii: 362O9ITL9D
RinglACETAMINOPHENSato Pharmaceutical Co., Ltd.ba5a0286-3e0f-4bef-96e5-29d92f51f4322023-12-06WarningsExact identifier
unii: 362O9ITL9D
Childrens Plus FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1598e6f8-08ee-4216-a5ab-76cad37b09a72023-12-06WarningsExact identifier
unii: 362O9ITL9D
Pain Relief ChildrensACETAMINOPHENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)41633554-474e-4d3c-9187-d90487d2ae8c2023-12-06WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
unii: 362O9ITL9D
Stona-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc12023-12-04WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGranules Pharmaceuticals Inc.2407efce-b77e-4072-bc4b-62c789d01e1a2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
TopCare Day Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC14d53907-a4a2-4a0f-b2d6-33474945f9e12023-12-04WarningsExact identifier
unii: 362O9ITL9D
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
unii: 362O9ITL9D
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEAurohealth LLCf5465419-1453-4ccc-a517-1fdff1eb3c052023-12-01WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENProficient Rx LP402c8563-b14b-453f-80bc-4275f1c737022023-12-01WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb94ab2bc-6ef3-4a64-ba05-a0a4e37794fa2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack6e28cc29-a85a-44d0-9c5b-bd0934ece64d2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAurohealth LLC3ba51b52-7ae6-4335-b178-1b7b6ef362272023-11-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLCbc03fa56-8880-4bbd-81a0-91853fecdd4e2023-11-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC03d42892-4465-4089-90a7-cd5f00c356022023-11-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCcc0ab7a1-e535-4dc8-962f-c58949fc17372023-11-29WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAurohealth LLCa4ff94b9-c248-4cd3-8491-38e9555cc22e2023-11-29WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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