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 87 of 159 · 3,172 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_Rx90a11364-fc42-e94e-e053-2a95a90a97822025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049214
unii: 362O9ITL9D
unii: C1ENJ2TE6C
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
unii: 362O9ITL9D
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
unii: 362O9ITL9D
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
unii: 362O9ITL9D
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
unii: 362O9ITL9D
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
unii: 362O9ITL9D
Dual ActionACETAMINOPHEN AND IBUPROFEN (NSAID) TABLETS, 250 MG/ 125 MGDr. Reddy's Laboratories Incc8a8a18a-6766-37a9-d0f0-f9380fb5b0e82025-07-18WarningsExact identifier
unii: 362O9ITL9D
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
unii: 362O9ITL9D
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAYACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1a17b24a-8022-4e2f-e063-6294a90af2762025-07-17WarningsExact identifier
unii: 362O9ITL9D
Ampigrin Ultra Forte NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e71c3-fe7c-77c7-e053-2995a90a34b22025-07-17WarningsExact identifier
unii: 362O9ITL9D
NitecinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCdfb56532-6f72-1e4d-e053-2a95a90a1c052025-07-17WarningsExact identifier
unii: 362O9ITL9D
tabcin NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLC0b3ed2bb-88ed-699e-e063-6394a90ac0232025-07-17WarningsExact identifier
unii: 362O9ITL9D
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
unii: 362O9ITL9D
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
unii: 362O9ITL9D
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
unii: 362O9ITL9D
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
unii: 362O9ITL9D
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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