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 143 of 158 · 3,158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butal/APAP/CaffBUTAL/APAP/CAFFDirect_Rxf6dc9bbc-3331-b422-e053-6394a90af9a12024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
unii: 362O9ITL9D
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENLupin Pharmaceuticals,Inc.26a2178e-e0e5-4d61-81fd-e30a3142f1f22024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC155a7168-b568-41f4-b8a2-214889b4eccf2024-02-02WarningsExact identifier
unii: 362O9ITL9D
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
unii: 362O9ITL9D
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
unii: 362O9ITL9D
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
unii: 362O9ITL9D
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
unii: 362O9ITL9D
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
unii: 362O9ITL9D
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack6a593fc7-49b0-4910-8a0c-5e718e5ff45b2024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
unii: 362O9ITL9D
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESeton Pharmaceuticals LLC3c5cefe3-c84e-4380-97f3-78e3fe92543a2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDELupin Pharmaceuticals,Inc.801cb437-c189-44f5-83eb-a51c365d8a6b2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

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