FDA.reportPublic FDA data

NDC 54868-4237-1 - 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
54868-4237-1
Package NDCs from labels
54868-4237-0, 54868-4237-4, 54868-4237-1
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 70 of 185 · 3,699 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
SCROPHULOUS HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEABioActive Nutritional, Inc.3421f76b-bcde-42b5-a04b-05099520e6612025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC392a846e-7325-462d-b19b-8afda44c5cb02025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
unii: 362O9ITL9D
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWALGREEN COMPANY2789fdef-2d8e-6247-e063-6394a90a974b2025-12-16WarningsExact identifier
unii: 362O9ITL9D
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCNatural Creations, Inc9dd6f22e-45b0-4771-80f7-6f530c96350d2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe2025-12-16WarningsExact identifier
unii: 362O9ITL9D
ScarCALENDULA, GRAPHITES, HYPERICUM PERFORATUM, STAPHYSAGRIA, SILICEA, THIOSINAMINUMNatural Creations, Incf83f2234-24dc-4fb9-972e-ada049d940ed2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e70d0784-53bc-4910-aade-3c9ad6e364412025-12-16WarningsExact identifier
unii: 362O9ITL9D
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
unii: 362O9ITL9D
Pain and SinusACETAMINOPHEN AND PHENYLEPHRINEJHK Inc dba American Safety & First Aid88f86f5a-cc2b-4c75-b7a4-f2021922280b2025-12-16WarningsExact identifier
unii: 362O9ITL9D
SCROPHULOUS HPBARIUM CARBONATE, BROMINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, FERROUS IODIDE, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.fb30a5cf-7d25-48f3-a6e6-0cc4c1f418922025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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