FDA.reportPublic FDA data

NDC 54868-2281-2 - 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
54868-2281
Requested NDC
54868-2281-2
Package NDCs from labels
54868-2281-1, 54868-2281-4, 54868-2281-5, 54868-2281-2
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
54868-2281-1HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLE, PLASTICTABLET305
54868-2281-4HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLE, PLASTICTABLET105
54868-2281-5HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLE, PLASTICTABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2281HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]53 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
54868-2281-0EA - Each54868-2281b4778b12-14ec-4238-a618-351a31da21f212012-07-24
54868-2281-1EA - Each54868-2281048e23fa-8294-4fb3-b9c7-bfe07377e40a12012-07-24
54868-2281-2EA - Each54868-2281ddc561d1-8752-4557-b3cb-392d05ffba4b12012-07-24
54868-2281-3EA - Each54868-22812dbf3c72-2d91-41df-97a6-7de78196709e12012-07-24
54868-2281-4EA - Each54868-2281f03ef2d1-f656-4696-a722-47f8b29b831a12012-07-24
54868-2281-5EA - Each54868-2281f8904bc8-a670-447e-aba2-070869cfa3fd12012-07-24
54868-2281-7EA - Each54868-22816f618308-f34d-4bc4-80bd-457a7c93849712012-07-24
54868-2281-8EA - Each54868-228159d13c2e-980a-4582-a825-9941b6af6e9712012-07-24
54868-2281-9EA - Each54868-228173e15d55-0602-4d2e-ae04-268a5f4e135f12012-07-24

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 49 of 183 · 3,644 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENA-S Medication Solutionsfc61200e-cc40-47c4-8792-c939c9877ae22026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Severe Allergy And Sinus Headache Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacyb3c744b8-aa93-505d-f8cf-07995da4283d2026-02-06WarningsExact identifier
unii: 362O9ITL9D
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATEWinCo Foods, LLC911e6a51-c0f0-491a-b70c-00011ed5e35b2026-02-06WarningsExact identifier
unii: 362O9ITL9D
Severe Sinus Daytime, Non-DrowsyACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycc0dc951-5024-4517-9d38-a01699407e7e2026-02-06WarningsExact identifier
unii: 362O9ITL9D
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
unii: 362O9ITL9D
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
unii: 362O9ITL9D
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENKVK-Tech, Inc.f1063950-b302-4898-81c2-b1626c9c16ef2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857005
unii: NO70W886KK
unii: 362O9ITL9D
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rx446e9f78-4034-5bb4-e063-6394a90ac7392026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rx446f01f0-2853-d104-e063-6394a90ae3512026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAmerican Health Packaging88e5345a-f240-473c-b329-2b0aa5f081f92026-02-04WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
unii: 362O9ITL9D
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact identifier
unii: 362O9ITL9D
Pain Relief childrensACETAMINOPHENCVS PHARMACYb8ab85a6-3eab-4ef4-a13d-5ac300480f632026-02-03WarningsExact identifier
unii: 362O9ITL9D
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEDiscount Drug Martba64c29d-4a50-47b7-be6b-6cf7db11a97a2026-02-03WarningsExact identifier
unii: 362O9ITL9D
Motrin Dual Action With TylenolACETAMINOPHEN AND IBUPROFENKenvue Brands LLCf2ee9cf5-02b7-6612-e053-2995a90a90c42026-02-03WarningsExact identifier
unii: 362O9ITL9D
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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