FDA.reportPublic FDA data

NDC 52959-371 - Theracodophen-650

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
52959-371
Package NDCs from labels
52959-371-60
Manufacturer
Physician Therapeutics LLC | Amneal Pharmaceuticals | H.J. Harkins Company, Inc. | Targeted Medical Pharma Inc.
Effective date
2011-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Theracodophen-650Physician Therapeutics LLC | Amneal Pharmaceuticals | H.J. Harkins Company, Inc. | Targeted Medical Pharma Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-371-60Theracodophen-65060 in 1 BOTTLETABLET6010 mg8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-371THERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8Unmatched20110815_09c9f50f-e78a-463f-b6da-49bf64b4ed40.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKTHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7THERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
GELATININACTIVE INGREDIENT2G86QN327LTHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERACODOPHEN-650 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]8

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 1 of 163 · 3,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
unii: 362O9ITL9D
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 362O9ITL9D
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsExact identifier
unii: 362O9ITL9D
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
unii: 362O9ITL9D
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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