FDA.reportPublic FDA data

NDC 54868-4237-5 - 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
54868-4237-5
Package NDCs from labels
54868-4237-0, 54868-4237-4, 54868-4237-5
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 94 of 184 · 3,664 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive rapid release pain reliefACETAMINOPHENStrategic Sourcing Services LLCd2130173-b107-4ae6-a1f7-6db467da38202025-08-30WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPrecision Dose, Inc.e1d4f562-433c-4344-9b77-1a7c731d1be52025-08-29WarningsExact identifier
unii: 362O9ITL9D
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
unii: 362O9ITL9D
ENDOCETOXYCODONE AND ACETAMINOPHENRedpharm Drug3251c37b-8e31-a613-e063-6294a90ae9822025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Equaline migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFI28ab87e5-6b7d-4737-95e8-4f842ecd94082025-08-28WarningsExact identifier
unii: 362O9ITL9D
Sinus Relief Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company98de5cff-3ff5-49b0-bef9-5b9ebb86491e2025-08-27WarningsExact identifier
unii: 362O9ITL9D
Nighttime SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEH E B0a178114-0748-4a92-9b60-a7a0a8b722872025-08-26WarningsExact identifier
unii: 362O9ITL9D
good neighbor pharmacy migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen201f101a-3b53-4349-896c-6b86cdd9b8312025-08-26WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.4d5bfd3a-3793-4d24-aedd-c04fa34ea7362025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
pain reliefACETAMINOPHENSafeway0e0a73f9-8c18-41fd-812e-8be20287e77a2025-08-26WarningsExact identifier
unii: 362O9ITL9D
good sense pain relief arthritis painACETAMINOPHENBryant Ranch Prepack7b0b07f6-242a-4e1a-ab39-84f0334d47162025-08-26WarningsExact identifier
unii: 362O9ITL9D
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
CAREONE DUAL ACTIONACETAMINOPHEN, IBUPROFENRetail Business Services, LLC76302cb3-0371-49ce-85d8-5f3785c370b02025-08-25WarningsExact identifier
unii: 362O9ITL9D
Topcare Pain ReliefACETAMINOPHENSixarp, LLC2e20be17-2b6c-1a07-e063-6394a90acdd32025-08-25WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC997eb228-09cb-47ad-acbb-363b05c676352025-08-25WarningsExact identifier
unii: 362O9ITL9D
SanaTos Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLCdf260190-89e7-b338-e053-2995a90a32cb2025-08-22WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.ed6af366-753c-4f3b-a6a2-c9a183c500352025-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857002
rxcui: 856999
unii: NO70W886KK
unii: 362O9ITL9D
Severe Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy258d27a9-fea6-4076-8dfa-77c7e982d2502025-08-20WarningsExact identifier
unii: 362O9ITL9D
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Inc.0c3ed6fe-8dce-0496-e063-6394a90add562025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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