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 39 of 153 · 3,051 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
unii: 362O9ITL9D
M-PAPACETAMINOPHENBryant Ranch Prepackc6cec390-004e-45f6-9388-c662a979f37d2026-03-17WarningsExact identifier
unii: 362O9ITL9D
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS Pharmacy48438525-e49f-9303-e063-6394a90a44f22026-03-16WarningsExact identifier
unii: 362O9ITL9D
DaytimeACETAMINOPHEN, GUAIFENESINCVS HEALTH CORP4985c332-6602-fd2d-e063-6394a90accd22026-03-16WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLH E B21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a2026-03-16WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTopco Associates, LLCeaa98783-5800-4ae9-832f-f4a1fd1790fd2026-03-16WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc96d8b6d1-8a51-41a4-80d3-fab61492b3cc2026-03-14WarningsExact identifier
unii: 362O9ITL9D
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Incc0b36e4d-3667-58f6-e053-2a95a90afad72026-03-14WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inca16a85c2-e1fd-4d1a-a650-271ae430eb4f2026-03-14WarningsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackc83366d9-db60-45eb-9c2b-a2c58d45c82c2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENGrocery Outlet, Inc.4454d02a-ba49-6c8c-e063-6294a90a47092026-03-12WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)db0f0164-3cbd-49b0-91ef-2e5218b09c3f2026-03-12WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC6207ef50-4f28-4dbc-9a52-f44dd53d2a4f2026-03-11WarningsExact identifier
unii: 362O9ITL9D
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.66e184cd-fa32-431f-b843-9c4bea12593b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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