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 154 of 158 · 3,148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LPd9fa3057-c7a5-46cf-a79e-abf99a4f804d2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
topcare 8 hr arthritis pain reliefACETAMINOPHENTopco Associates LLC0d427360-ff9d-4e98-b218-6eb6c015dc6a2022-05-23WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.5c00f98f-dcab-4bdb-901e-02eb873dea312022-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.3e89f02d-b6e7-4641-82d4-f756518a89142022-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049214
unii: 362O9ITL9D
unii: C1ENJ2TE6C
TrezixACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEProficient Rx LP45c3c2a1-6a89-471e-b6d4-5a4cd73b987a2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPc6210466-5feb-45d9-b637-b3f482bc3c2b2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP75b50751-5237-4e3e-b7ee-1605c0602f3b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care acetaminophenACETAMINOPHENAmazon.com Services LLCb0c55ac4-0b1a-4411-9df3-6bb64e20ea222022-03-23WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb3c229a4-c772-70fb-e053-2a95a90a72db2022-03-11WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSolupharm Pharmazeutische Erzeugnisse GmbHd92be8ae-3173-0a9d-e053-2995a90abc632022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCivica, Inc.1b5ca3e0-ce08-4e11-9385-9ec22e5abb5b2022-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LP7a2219a8-8aaf-44ad-9808-b67923df361a2022-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.52693021-f60f-43bc-9b05-43db186213462022-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cold MedicineCOLD MEDICINEAllegiant Health443fbc44-2c33-4316-ad31-dcc5a5aa8f522021-11-23WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthPAIN RELIEFAllegiant Healthd41d2319-8eed-4df9-813c-313497ceb8b42021-11-23WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthPAIN RELIEF PMAllegiant Health4c9969be-a01f-4ca4-800a-e404229ce28b2021-11-23WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Health9d348550-060b-410f-8c1e-8f43d00b860e2021-11-22WarningsExact identifier
unii: 362O9ITL9D
NOCOLD-FACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDELydia Co., Ltd.d0b20c56-de2a-1489-e053-2995a90a6a062021-11-13WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extended-ReleaseACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fc9-8421-e053-2a95a90acf4a2021-10-28WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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