FDA.reportPublic FDA data

NDC 54868-4237-5 - 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
54868-4237-5
Package NDCs from labels
54868-4237-0, 54868-4237-4, 54868-4237-5
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 63 of 185 · 3,699 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
unii: FZ989GH94E
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLC0181af13-da32-4431-be39-c31fdfac92022025-12-29WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa690f5c5-ff41-4072-e053-2995a90a8e552025-12-29WarningsExact identifier
unii: 362O9ITL9D
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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