FDA.reportPublic FDA data

NDC 54868-3585-2 - 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
54868-3585-2
Package NDCs from labels
54868-3585-5, 54868-3585-2
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 129 of 182 · 3,634 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenPAIN RELIEVERMcKesson9d620700-5d00-475f-e053-2995a90a9a3f2024-10-28WarningsExact identifier
unii: 362O9ITL9D
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
unii: 362O9ITL9D
Junior Acetaminophen Ages 6-11ACETAMINOPHENChain Drug Consortiumd356bc9c-66f1-45c3-a455-98c0b8890f782024-10-28WarningsExact identifier
unii: 362O9ITL9D
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
Signature Care Non drowsy Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway25a26577-a9f8-49cb-9d75-d8c471e4aaf62024-10-28WarningsExact identifier
unii: 362O9ITL9D
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e2024-10-28WarningsExact identifier
unii: 362O9ITL9D
Leader Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderd38537c6-9553-4e93-a83e-11ed48c955ab2024-10-28WarningsExact identifier
unii: 362O9ITL9D
Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy2b3a1997-f382-4843-a44b-d80d1ad21a902024-10-28WarningsExact identifier
unii: 362O9ITL9D
daytime cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1740ccfc-6e68-46f4-a1ba-48fe092f0aa02024-10-28WarningsExact identifier
unii: 362O9ITL9D
night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.d3bd0632-328c-4ad7-bb44-8383e1e51b8c2024-10-28WarningsExact identifier
unii: 362O9ITL9D
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
leader AcetaminophenACETAMINOPHENCardinal Health 110, LLC. dba Leader36bdcac9-eed4-40f9-a6f2-4c1e773a6b502024-10-25WarningsExact identifier
unii: 362O9ITL9D
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy1c341cf5-ac33-4a6e-b023-a23d280d496c2024-10-25WarningsExact identifier
unii: 362O9ITL9D
GOODYS PMACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEMedtech Products Inc.db5d6c2b-688e-4e88-a42d-0fa2b0d8140b2024-10-25WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyb6d9f421-b236-4660-be7f-85a878f2fc612024-10-25WarningsExact identifier
unii: 362O9ITL9D
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.16d774cc-4247-4bf8-9b5a-c338ffebda3d2024-10-25WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLC1deb60f3-e9be-4756-b0c1-527ef00dc7412024-10-24WarningsExact identifier
unii: 362O9ITL9D
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
unii: 362O9ITL9D
Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC68a5930b-37db-439d-8fb9-7d7de07d84652024-10-24WarningsExact identifier
unii: 362O9ITL9D
sinus pressure pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INCbb0225d5-6c32-2c64-e053-2995a90a829b2024-10-24WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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