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 63 of 182 · 3,634 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact identifier
unii: 362O9ITL9D
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
unii: 362O9ITL9D
Nite-Time COLD/FLU Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
unii: 362O9ITL9D
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPioneer Life Sciences, LLCaa2de3a5-a20d-33c6-e053-2a95a90ada3e2025-12-26WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENDiscount Drug Mart2aa0f9f3-924c-4a4a-bb5f-2a326acc24082025-12-26WarningsExact identifier
unii: 362O9ITL9D
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRedPharm Drug2c6014de-8901-9d83-e063-6294a90ad37b2025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
unii: 362O9ITL9D
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
unii: 362O9ITL9D
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
unii: 362O9ITL9D
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
unii: 362O9ITL9D
Pharbetol Regular strengthACETAMINOPHENPharbest Pharmaceuticals, Inc.e0a39957-d918-4125-88f9-0e550b976fa12025-12-24WarningsExact identifier
unii: 362O9ITL9D
PHARBETOLACETAMINOPHEN 500MGPharbest Pharmaceuticals, Inc.27337be9-e279-460e-903e-ae44630995992025-12-24WarningsExact identifier
unii: 362O9ITL9D
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46996bbf-948c-0aba-e063-6394a90a09e32025-12-23WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.1d2e2a5a-099b-41b3-82bd-5bf704377f782025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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