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 181 of 182 · 3,634 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 362O9ITL9D
H-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENAdvance Pharmaceutical Inc.3793a17e-13bf-4d27-b8fa-6753b760f8202017-12-22WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN PMACETAMINOPHEN PMAdvance Pharmaceutical Inc.b172226e-8f2a-4d9c-b7c7-dd737b90463a2017-12-22WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENAdvance Pharmaceutical Inc.5c75dc7f-06ae-440e-90ed-d7753eaa786e2017-12-22WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENPuraCap Pharmaceutical LLCf3c57374-1408-4459-a4de-ad12c2fc6b612017-11-09WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENCVS PHARMACY, INC.3f9c230b-e6ea-4786-992b-9c72044252092017-11-09WarningsExact identifier
unii: 362O9ITL9D
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENRichmond Pharmaceuticals, Inc.cda8e158-01ac-4c08-826e-4a0c7278e8052017-10-30WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENRichmond Pharmaceuticals, Inc.a30388fa-0d85-4eb3-babd-228170ebe96d2017-10-30WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENRichmond Pharmaceuticals, Inc.ad087586-67cd-4875-b0e6-3fba06ea0f652017-10-30WarningsExact identifier
unii: 362O9ITL9D
Chewable Acetaminophen ChildrensACETAMINOPHENRichmond Pharmaceuticals, Inc.a5dd9031-a960-4a98-ab71-05b079183f1a2017-10-30WarningsExact identifier
unii: 362O9ITL9D
NightTime Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINEVelocity Pharma516fc924-61f0-40ee-9688-3c6da817b4622017-09-11WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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