FDA.reportPublic FDA data

NDC 52959-312 - Theracodophen-Low-90

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
52959-312
Package NDCs from labels
52959-312-30
Manufacturer
Physician Therapeutics LLC | Amneal Pharmaceuticals, LLC | 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-Low-90Physician Therapeutics LLC | Amneal Pharmaceuticals, LLC | 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
52959-312-30Theracodophen-Low-9030 in 1 BOTTLETABLET305 mg13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-312THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13Unmatched20110812_5dbfb94c-0bbf-4096-baf5-c6690a2d0997.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
ARGININEINACTIVE INGREDIENT94ZLA3W45FTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
CHOLINE BITARTRATEINACTIVE INGREDIENT6K2W7T9V6YTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
CINNAMONINACTIVE INGREDIENT5S29HWU6QBTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
COCOAINACTIVE INGREDIENTD9108TZ9KGTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
GELATININACTIVE INGREDIENT2G86QN327LTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
GLUTAMINEINACTIVE INGREDIENT0RH81L854JTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
GRAPEINACTIVE INGREDIENT6X543N684KTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
HISTIDINEINACTIVE INGREDIENT4QD397987ETHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
THEOBROMINEINACTIVE INGREDIENTOBD445WZ5PTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13
WHEYINACTIVE INGREDIENT8617Z5FMF6THERACODOPHEN-LOW-90 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]13

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 8 of 290 · 5,782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
unii: 362O9ITL9D
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC212acd54-6ff0-446a-a3bb-3b40e12797112026-08-13WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
unii: 362O9ITL9D
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)af35c833-316a-4d21-bd3a-9b71558cadbf2026-08-12WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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