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 77 of 152 · 3,032 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Physicians Care Non-Drowsy Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAcme United186ec543-1f23-75d6-e063-6294a90a46b92025-09-08WarningsExact identifier
unii: 362O9ITL9D
PhysiciansCare Allergy Multi-Symptom ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEAcme United Corporationfd101c27-6ba9-4cd3-baec-a354504c37a02025-09-08WarningsExact identifier
unii: 362O9ITL9D
Green Guard Maximum Non-AspirinACETAMINOPHENUnifirst First Aid Corporation30f77d4d-839e-4d96-9f24-0254e6a47b812025-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi-Symptom Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,Unifirst First Aid Corporatione6ea6faf-baff-a130-e053-2a95a90a085a2025-09-08WarningsExact identifier
unii: 362O9ITL9D
Green Guard Cramp ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEUnifirst First Aid Corporatione6edff0f-94e4-7eba-e053-2a95a90a1d572025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique APAPACETAMINOPHENUnifirst First Aid Corporation04805d9c-d959-4870-a185-48b58a8808802025-09-08WarningsExact identifier
unii: 362O9ITL9D
Green Guard Maximum Strength Non-AspirinACETAMINOPHENUnifirst First Aid Corporationf77c9554-d1c2-1682-e053-6294a90ac5722025-09-08WarningsExact identifier
unii: 362O9ITL9D
MEDIQUE APAP Extra StrengthACETAMINOPHENUnifirst First Aid Corporation56822785-d5fb-4869-971e-5de637c2eda82025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique Extra Strength APAPACETAMINOPHENUnifirst First Aid Corporationf77f8ef5-4aa8-fa80-e053-6394a90a70c22025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINEUnifirst First Aid Corporationc2d7af6b-f477-2462-e053-2995a90aff0f2025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique Extra Strength ApapACETAMINOPHENUnifirst First Aid Corporation14bcbaf9-76b6-f8ba-e063-6294a90a91f62025-09-08WarningsExact identifier
unii: 362O9ITL9D
Crane Safety XS Non-AspirinACETAMINOPHEN 500 MGCrane Safety LLC9626b3b2-c8ba-5a58-e053-2995a90a35c82025-09-08WarningsExact identifier
unii: 362O9ITL9D
Medique at Home APAPACETAMINOPHENUnifirst First Aid Corporationb5582e23-5079-1f2b-e053-2a95a90ad8002025-09-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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