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 18 of 159 · 3,172 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI490766e7-1781-4b2b-a8f4-d4efb9fff5602026-06-19WarningsExact identifier
unii: 362O9ITL9D
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
unii: 362O9ITL9D
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack8ad0df84-e3f6-4c1d-b791-c8467eb984aa2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
dg health 8 hr arthritis pain reliefACETAMINOPHENDolgencorp Incfc7838a7-fc6d-41b7-b8e4-97bee2bfa6d42026-06-17WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
unii: 362O9ITL9D
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafewayac0380ad-c9fa-4bda-ab84-c2e6aa672bdf2026-06-17WarningsExact identifier
unii: 362O9ITL9D
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
unii: 362O9ITL9D
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack0e4dd113-87ab-4a5d-846a-446db3cfd4692026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Childrens Pain and Fever ReliefACETAMINOPHENChain Drug Marketing Association, Inc.420a1e05-caa6-481f-bdab-a670f0220f962026-06-16WarningsExact identifier
unii: 362O9ITL9D
Equate Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.4b111580-cd20-43ec-9ff4-4b9f74f7d2e82026-06-16WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
unii: 362O9ITL9D
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke84ea009-3cab-4721-bd21-1123eccce5152026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact identifier
unii: 362O9ITL9D
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact identifier
unii: 362O9ITL9D
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
unii: 362O9ITL9D
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENGranules India Limited00eb3e4b-1507-4c9a-83a5-ef50cb3127532026-06-15WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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