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 102 of 158 · 3,158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUBLIX SUPER MARKETS INCACETAMINOPHEN, ASPIRIN AND CAFFEINEPUBLIX SUPER MARKETS INC08a46808-2bb2-0b40-e063-6394a90af80e2025-01-02WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINENuCare Pharmaceuticals, Inc.4ecb7bdc-4a43-7444-e054-00144ff88e882025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Multi-Symptom Nighttime Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRAdvanced Rx LLCa75553bd-f3f0-47bd-b3c3-aeeb0d1a81b42025-01-01WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP5d9123f6-b322-4fa0-bf48-6335a6adcbb82025-01-01Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Headache, Circle KACETAMINOPHEN, CAFFEINE, ASPIRIN TABLETLil' Drug Store Products, Inc.e711ff0a-2fa0-1f2a-e053-2a95a90a4e382024-12-31WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Headache, Lil Drug StoreEXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0c41deda-490b-f5d2-e063-6394a90a50472024-12-31WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Headache, Circle KACETAMINOPHEN/ASPIRIN/CAFFEINE TABLETLil' Drug Store Products, Inc.d18e1631-de43-4b29-e053-2995a90af56d2024-12-31WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED TABLETLil' Drug Store Products, Inc.e5f9def4-4cf5-4e06-e053-2995a90a07ea2024-12-31WarningsExact identifier
unii: 362O9ITL9D
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenEXTRA STRENGTH PAIN RELIEFNuCare Pharmaceuticals,Inc.a32f346e-71d0-cc11-e053-2a95a90ae88c2024-12-31WarningsExact identifier
unii: 362O9ITL9D
Butalbital/Acetaminophen/CaffeineBUTALBITAL/ACETAMINOPHEN/CAFFEINEAdvanced Rx Pharmacy of Tennessee, LLCf16429e2-4944-5bbc-e053-2a95a90ab5282024-12-31Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEDollar General4907056d-6013-46b1-ae86-469dc30015912024-12-31WarningsExact identifier
unii: 362O9ITL9D
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
unii: 362O9ITL9D
Pediacare Childrens GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHf9d531a2-234c-4feb-8f05-212dbee83dfe2024-12-30WarningsExact identifier
unii: 362O9ITL9D
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store Products, Inc.ef6836fa-d104-d7b3-e053-2a95a90af2b82024-12-30WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fd2b46-683e-4cf5-e053-2995a90a55122024-12-30WarningsExact identifier
unii: 362O9ITL9D
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS Pharmacy6f880abe-5284-42b0-9db6-b071444b197b2024-12-27WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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