NDC 0406-0357-23 - 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
0406-0357
Requested NDC
0406-0357-23
Package NDCs from labels
0406-0357-23
Manufacturer
Physicians Total Care, Inc.
Effective date
2014-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIIPhysicians Total Care, Inc.2014-04-03HUMAN PRESCRIPTION DRUG LABEL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIILiberty Pharmaceuticals, Inc.2013-09-09HUMAN PRESCRIPTION DRUG LABEL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN - Medsource PharmaceuticalsMedsource Pharmaceuticals2012-07-24HUMAN PRESCRIPTION DRUG LABEL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIIISTAT Rx USA LLC | PSS World Medical Inc.2012-01-31HUMAN PRESCRIPTION DRUG LABEL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN - Contract Pharmacy Services-PAContract Pharmacy Services-PA2012-01-23HUMAN PRESCRIPTION DRUG LABEL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN - STAT RX USA LLCSTAT RX USA LLC2010-06-29HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0357-01EA - Each0406-03575e99876e-18d3-4aab-bb1f-a29985e52f6712012-07-24
0406-0357-05EA - Each0406-0357cf68f85b-0a2e-4c78-b3c5-784d4f5d751d12012-07-24
0406-0357-09EA - Each0406-035706374d9c-9f07-4a1a-9388-c722618ccd1b12012-07-24
0406-0357-23EA - Each0406-0357ed749a1a-614e-44a2-b052-4e92c16e8a8d12013-03-03
0406-0357-62EA - Each0406-0357a2a0c72b-664a-4de5-a43e-c3235fb5c80e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]9
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
HYDROCODONE BITARTRATeACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]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 15 of 186 · 3,704 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
unii: 362O9ITL9D
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack8a4cf981-37f7-4bc9-a9d7-b134a5fd08942026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leaderf1cd0d59-12a8-4ff2-942a-6faa6907ef052026-07-13WarningsExact identifier
unii: 362O9ITL9D
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
unii: 362O9ITL9D
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
unii: 362O9ITL9D
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
unii: 362O9ITL9D
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
unii: 362O9ITL9D
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
unii: 362O9ITL9D
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
unii: 362O9ITL9D
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
unii: 362O9ITL9D
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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