FDA.reportPublic FDA data

NDC 68084-863-11 - Hydrocodone Bitartrate 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
68084-863
Requested NDC
68084-863-11
Package NDCs from labels
68084-863-11, 68084-863-09, 68084-863-01
Manufacturer
American Health Packaging
Effective date
2019-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocodone Bitartrate And Acetaminophen - American Health PackagingAmerican Health Packaging2019-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-863-01EA - Each68084-8633c3b3c84-f104-4d49-addc-60e33f1a672112015-05-05
68084-863-09EA - Each68084-86396b507c2-c6d7-4346-8d21-fb43afefa49a12014-11-05
68084-863-11EA - Each68084-863a9340107-7d95-4e34-942e-3f8c8d997fb412014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]3

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 4 of 155 · 3,096 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
unii: 362O9ITL9D
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
DG Health 8 Hour Pain ReliefACETAMINOPHENDolgencorp Incd102e8a2-2fff-48cb-9864-7582fde956ed2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: 362O9ITL9D
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
unii: 362O9ITL9D
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEKVK-Tech, Inc.26d7c90c-5e6b-4bdb-b06f-c76173a01c212026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Feverall ChildrensACETAMINOPHENSun Pharmaceutical Industries, Inc.861e2987-5473-45b0-b2a6-f980a9b0e8092026-08-24WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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