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 150 of 184 · 3,664 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS07d34e7a-c0c6-f3c4-e063-6294a90aa5c32024-05-18WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC10ee2f40-858d-bed4-e063-6394a90a86bb2024-05-17WarningsExact identifier
unii: 362O9ITL9D
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutionsbcb7eb24-16cb-439e-879f-48d2f5e8ba832024-05-17WarningsExact identifier
unii: 362O9ITL9D
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLC26266777-185d-4110-a8a7-56846aab25422024-05-17WarningsExact identifier
unii: 362O9ITL9D
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutions1b4db77f-b254-4db5-8e98-d46850140a9b2024-05-16WarningsExact identifier
unii: 362O9ITL9D
TenconBUTALBITAL AND ACETAMINOPHENEl Dorado Distributors LLC4e4a9925-67aa-4be7-8bb7-c8b058ffe2232024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
KOSHER MEDS Childrens Pain and FeverACETAMINOPHENMollec Inc4d01c9ee-26be-4cdd-b52d-7fa344c1933a2024-05-15WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.d6ac0d70-0511-4ec8-bb35-8b2e0e3d77422024-05-15WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113df1bc-a217-33ea-e063-6294a90a46432024-05-14WarningsExact identifier
unii: 362O9ITL9D
Cold Flu and Sore Throat Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway, Inc.6c952c81-c8b6-4e74-abd8-781f6f44736b2024-05-14WarningsExact identifier
unii: 362O9ITL9D
Pain and Sinus RelieverACETAMINOPHEN AND PHENYLEPHRINEJHK DBA American Safety & First Aid249373c6-f56f-4bd3-9cef-98b7ee73457d2024-05-14WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.a70ead03-6d2c-44c1-9ae5-f6c4094821ec2024-05-14WarningsExact identifier
unii: 362O9ITL9D
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.4510fe59-cc28-4585-925f-42508a60abd02024-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Day Time Cold and Flu Relief non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.cc450f89-a156-48e0-82ae-19782f13c2ca2024-05-13WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.ef0cd436-5e81-47a7-92d6-58495283ab282024-05-13WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENP & L Development, LLC1c081a7c-8cff-4253-97ac-5fa74a5c06682024-05-10WarningsExact identifier
unii: 362O9ITL9D
dg health childrens pain and feverACETAMINOPHENDolgencorp Inc1d794621-9836-4ab8-92ee-fcd9169645672024-05-09WarningsExact identifier
unii: 362O9ITL9D
EMF Protect and BalanceALFALFA, FUCUS VESICULOSUS, KALI PHOSPHORICUM, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, FERRUM METALLICUM, CADMIUM SULPHURATUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, YTTERBIUM OXIDE, TARENTULA CUBENSIS, X-RAY, CUPRUM METALLICUM, SILICEADeseret Biologicals, Inc.df7e925e-00d1-4b0c-8a78-ad38148bc3602024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4
Multiple MiasmARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SULPHUR, ALOE, CARCINOSIN, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Inc.0cf54ec3-d731-4f27-89fd-4571d991a6152024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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