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 68 of 182 · 3,634 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENRITE AIDd20b4682-fed2-3ea2-e053-2995a90aa47e2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENFAMILY DOLLARf824602a-8e7b-b8c3-e053-6294a90a6d9d2025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENFamily Dollarfe095058-5ecb-75b3-e053-6394a90afb6c2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINEFAMILY DOLLARf837e190-6fb3-e22e-e053-6394a90a12e62025-12-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRITE AIDd20a7f7a-febf-54f9-e053-2a95a90a06b12025-12-19WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RITE AIDe64c0ec1-2889-96d1-e053-2995a90a85682025-12-19WarningsExact identifier
unii: 362O9ITL9D
Day-Time COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLDiscount Drug Mart426db906-9aa4-448f-a361-09c1516efc252025-12-19WarningsExact identifier
unii: 362O9ITL9D
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
unii: 362O9ITL9D
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCaplin Steriles Limitedb6f83919-8608-4648-9ac6-e13eadac84042025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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