FDA.reportPublic FDA data

NDC 54868-0071-2 - 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
54868-0071
Requested NDC
54868-0071-2
Package NDCs from labels
54868-0071-0, 54868-0071-3, 54868-0071-6, 54868-0071-8, 54868-0071-2
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
54868-0071-0HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET609
54868-0071-3HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLETABLET109
54868-0071-6HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1209
54868-0071-8HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-0071HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PHYSICIANS TOTAL CARE, INC.]94 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
54868-0071-0EA - Each54868-00714c66ca5c-1dc6-41e0-b6a3-791d02d9e21c12012-07-24
54868-0071-1EA - Each54868-0071221dc4db-f3ba-4242-8592-21996ca5b8bf12012-07-24
54868-0071-2EA - Each54868-0071a9702e1e-4184-469d-85ae-68e585cfb59712012-07-24
54868-0071-3EA - Each54868-00715182450f-d646-44bf-8e9b-0dcd6701e79012012-07-24
54868-0071-4EA - Each54868-0071f0bf69b5-41e8-41d7-a2a5-1f13580535c612012-07-24
54868-0071-5EA - Each54868-0071a130d49e-80c4-4e91-b7d5-70a64f27be4e12012-07-24
54868-0071-6EA - Each54868-00718b3b5249-db87-4814-b437-39125a6619cf12012-07-24
54868-0071-7EA - Each54868-00710ee5146b-93e9-419d-b224-12d9b6f4262712013-02-11
54868-0071-8EA - Each54868-00717cc5100c-04b0-4589-9211-42c5535f9f3b12012-07-24
54868-0071-9EA - Each54868-0071306da74d-8fd3-48eb-9a7d-2e3c38e04c3312012-07-24

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 91 of 182 · 3,634 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Medi First Plus PMS ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEUnifirst First Aid Corporatione84007e7-498d-4662-e053-2995a90ad4de2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
unii: 362O9ITL9D
Travel Savvy Non-AspirinACETAMINOPHEN 325MGBellegrove Medical Supply, Inc.6ab08633-5d5a-42b2-e053-2991aa0ab41a2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Direct Safety Aspirin FreeACETAMINOPHENConney Safety Products, LLC1c7369ea-46b6-407c-aa4b-048eb72ff03f2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Direct Safety Extra Strength Aspirin FreeACETAMINOPHENConney Safety Products, LLCa524c36a-38f3-4266-8f45-589e194003282025-09-09WarningsExact identifier
unii: 362O9ITL9D
McKesson Acetaminophen 325ACETAMINOPHENMcKesson Medical-Surgical, Inc.bc2daba5-ce8b-bbda-e053-2a95a90a6f332025-09-09WarningsExact identifier
unii: 362O9ITL9D
Uline Acetaminophen Extra StrengthACETAMINOPHENUline90167594-0a49-2492-e053-2a95a90a14012025-09-09WarningsExact identifier
unii: 362O9ITL9D
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
Nighttime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc57c458ed-7987-453b-ab24-bbfa6580f9202025-09-09WarningsExact identifier
unii: 362O9ITL9D
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.38637189-d1ee-9405-e063-6394a90ae8b82025-09-09WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreensfd52d8d8-7cd1-4e92-86da-354a1d5213c22025-09-08WarningsExact identifier
unii: 362O9ITL9D
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: ETJ7Z6XBU4
Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione8e5fb21-a7fd-44d1-b9c4-83e949699ca62025-09-08WarningsExact identifier
unii: 362O9ITL9D
Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationf196f2c5-a100-42b1-bd01-0327b223838e2025-09-08WarningsExact identifier
unii: 362O9ITL9D
McKesson Sinus Pain and Pressure ReliefACETAMINOPHEN, PHENYLEPHRINE HCLMcKesson Medical-Surgicale0cbb213-4f4f-4045-e053-2a95a90a2a182025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation1f172d58-4050-424b-9743-130d8e618fe82025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Unifirst First Aid Corporatione8059137-efba-398c-e053-2a95a90a21f22025-09-08WarningsExact identifier
unii: 362O9ITL9D
Henry Schein AcetaminophenACETAMINOPHENHenry Schein, Inc.a56a5ca1-578c-40cd-90cc-cc4c2dfec8472025-09-08WarningsExact identifier
unii: 362O9ITL9D
Henry Schein AcetaminophenACETAMINOPHENHenry Schein, Inc.f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa2025-09-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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