FDA.reportPublic FDA data

NDC 54868-4237-7 - 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
54868-4237
Requested NDC
54868-4237-7
Package NDCs from labels
54868-4237-0, 54868-4237-4, 54868-4237-7
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-4237-0HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET209
54868-4237-4HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-4237HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]92 package rows20140403_8f5d00de-3b9b-46d4-b374-1cf329a4c1db.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-4237-0EA - Each54868-4237bb31b128-549e-4fdb-b9b0-543112f180ff12012-07-24
54868-4237-1EA - Each54868-42376d53310e-8693-4fcc-95a2-996e1379b41e12012-07-24
54868-4237-2EA - Each54868-4237441549e5-4acf-4495-8e66-8c3ab0757f4812012-07-24
54868-4237-3EA - Each54868-4237eaf77609-d88d-4670-9e0f-b97e0650317512012-07-24
54868-4237-4EA - Each54868-4237462f01cc-d536-466e-8c3e-e9115b6806d012012-07-24
54868-4237-5EA - Each54868-423754f6ca8c-9534-4202-aaa0-2fd2d5cbebeb12012-07-24
54868-4237-6EA - Each54868-42373292499c-9552-4e91-978a-77ed8d3649c112012-07-24
54868-4237-7EA - Each54868-4237304bcfcf-be65-4392-8f0c-cb64b50aef4412012-07-24
54868-4237-8EA - Each54868-4237d85056c3-fc5b-460b-ba98-3c98ed26cb1a12012-07-24
54868-4237-9EA - Each54868-4237d9477990-2170-4bd4-b78a-0f9227da55b712012-07-24

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

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 45 of 185 · 3,699 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.66e184cd-fa32-431f-b843-9c4bea12593b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857002
rxcui: 856999
unii: NO70W886KK
unii: 362O9ITL9D
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
unii: 362O9ITL9D
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack806a981f-85ff-4e58-8ff0-7ab02ed2e5c12026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857002
unii: NO70W886KK
unii: 362O9ITL9D
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
unii: 362O9ITL9D
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEMajor Pharmaceuticals0ca49c3c-f2cb-40e3-a7d5-5f48eca590162026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
unii: 362O9ITL9D
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
unii: 362O9ITL9D
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2a27da49-23d6-4035-8088-806ee22b98b02026-03-06WarningsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Inc8a201e19-3e47-7e58-e053-2995a90ab1d52026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact identifier
unii: 362O9ITL9D
Oxycodone/APAPOXYCODONE/APAPDirect_Rxe84245ca-957f-e85b-e053-2a95a90a836b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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