FDA.reportPublic FDA data

NDC 54868-3585-3 - 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
54868-3585
Requested NDC
54868-3585-3
Package NDCs from labels
54868-3585-5, 54868-3585-3
Manufacturer
Physicians Total Care, Inc.
Effective date
2014-02-17
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.2014-02-17HUMAN 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
54868-3585-5HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLE, PLASTICTABLET1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-3585HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]51 package rows20140217_ab52a549-8ecc-441a-8733-0fda146e9932.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-3585-0EA - Each54868-3585c3f7bb28-3883-49b4-9ab7-8a1084cadc9f12012-07-24
54868-3585-1EA - Each54868-358502f5ecde-20a9-45d9-9daf-0458cb4fc6a112012-07-24
54868-3585-2EA - Each54868-35859801ac21-07dc-4ae9-a3c4-ea74673ffb1d12012-07-24
54868-3585-3EA - Each54868-3585402e281e-0440-40a7-af62-c4ea8810f80512012-07-24
54868-3585-5EA - Each54868-358573a2c3fa-a4d6-4949-af38-cbf3656dbbc412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]5

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 70 of 182 · 3,634 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)df866cf6-0526-4e61-ac9b-245b57dd5df62025-12-16WarningsExact identifier
unii: 362O9ITL9D
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensc89200b6-4adb-452e-b931-07f631dad6412025-12-16WarningsExact identifier
unii: 362O9ITL9D
ONESSIP ADULT DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.45fa9159-d74c-063a-e063-6294a90a3ed02025-12-15WarningsExact identifier
unii: 362O9ITL9D
TYLENOL EXTRA STRENGTH, TRAVEL BASIXACETAMINOPHENLil' Drug Store Products, Inc.fa951d50-b79c-4161-8c81-fcf386b0964e2025-12-15WarningsExact identifier
unii: 362O9ITL9D
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA -TRP Companyaa2cd967-3c27-4afe-8751-7ea50ab629132025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company1c9c7944-31a9-4019-aad5-6b7f86084b532025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring Relief PM Nighttime FormulaARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company92ef0dd1-84f9-086c-e053-2a95a90ac6472025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Swimmers Ear Complete ReliefCALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIANTRP Companya3425da3-ace9-05c2-e053-2995a90ab09f2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Vanquish Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEDSE Healthcare Solutions, LLCcbf12223-ef44-494b-9d3c-971dce3c5ade2025-12-15WarningsExact identifier
unii: 362O9ITL9D
equate dual pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.09dc976b-6065-4aad-9d57-0fe5e88a722a2025-12-15WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWALGREENS40a1b354-9b2e-1cf3-e063-6394a90af1132025-12-13WarningsExact identifier
unii: 362O9ITL9D
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu maximum strengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationac01206f-a717-4c0b-8a03-fab0a4fd154b2025-12-12WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSMARKSANS PHARMA LIMITED46121a30-1361-4f2b-9f3f-3cedabd66c332025-12-12WarningsExact identifier
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLStrategic Sourcing Services LLCdcb80dd5-465d-4792-947a-3044e25a52842025-12-12WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN TABLETLil' Drug Store Products, Inc.45c397bd-a1ff-1246-e063-6394a90ac54a2025-12-12WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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