NDC 52959-190 - Theraproxen-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
52959-190
Package NDCs from labels
52959-190-30
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
Theraproxen-90Physician Therapeutics LLC | Amneal Pharmaceuticals | H.J. Harkins Company, Inc. | Targeted Medical Pharma Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL
Trepoxen-250Physician Therapeutics LLC | Amneal Pharmaceuticals | H.J. Harkins Company, Inc. | Targeted Medical Pharma Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL
TheraproxenPhysician Therapeutics LLC | Amneal Pharmaceuticals | Targeted Medical Pharma Inc. | H.J. Harkins Company, Inc2011-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-190-30Theraproxen-9060 in 1 BOTTLETABLET60250 mg14
52959-190-30Trepoxen-25030 in 1 BOTTLETABLET30250 mg13
52959-190-30Theraproxen30 in 1 BOTTLETABLET30250 mg7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-190THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14Unmatched20110812_29acd686-ca11-42b0-b5cd-5c1a04e45c29.zip
52959-190TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13Unmatched20110812_c957df9a-eb66-432f-a280-9cd74389d667.zip
52959-190THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7Unmatched20110812_c3f47985-0027-4fa7-aab2-5bc6ca79a6e8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
NAPROXENACTIVE INGREDIENT57Y76R9ATQTHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
NAPROXENACTIVE MOIETY57Y76R9ATQTHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
GELATININACTIVE INGREDIENT2G86QN327LTHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
HISTIDINEACTIVE INGREDIENT4QD397987ETREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
NAPROXENACTIVE INGREDIENT57Y76R9ATQTREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
HISTIDINEACTIVE MOIETY4QD397987ETREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
NAPROXENACTIVE MOIETY57Y76R9ATQTREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
GELATININACTIVE INGREDIENT2G86QN327LTREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
POVIDONEINACTIVE INGREDIENTFZ989GH94ETREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
NAPROXENACTIVE INGREDIENT57Y76R9ATQTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
NAPROXENACTIVE MOIETY57Y76R9ATQTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
GELATININACTIVE INGREDIENT2G86QN327LTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
POVIDONEINACTIVE INGREDIENTFZ989GH94ETHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]7

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 37 of 141 · 2,812 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
unii: FZ989GH94E
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: FZ989GH94E
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
unii: FZ989GH94E
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
unii: FZ989GH94E
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENQPharma, Inc.307aa67f-53b9-4c60-a328-091bbf6338d42025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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