FDA.reportPublic FDA data

NDC 68405-018-36 - 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
68405-018
Requested NDC
68405-018-36
Package NDCs from labels
68405-018-06, 68405-018-36
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68405-018-062019-10-29C16284748780-1960f7f55-d8cb-8e05-e053-dbdaa90a074aTheraproxen-90

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-190-30Theraproxen-9060 in 1 BOTTLETABLET60250 mg14
68405-018-06Theraproxen-901 in 1 KITKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68405-018THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]142 package rows20110812_29acd686-ca11-42b0-b5cd-5c1a04e45c29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68405-018-36EA - Each68405-018bc41efa4-9c22-4dc3-a28f-780ec898036512013-02-11

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

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 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENCoupler LLC5954565a-d9bd-9e26-e063-6294a90a03cb2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENREMEDYREPACK INC.88a548d1-97c0-46d0-825a-75ef689d64702026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.24d44eb6-921e-4150-a6b2-81f42ced32ab2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.49a00870-f580-4eb9-a95d-48fa956f147f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals, Inc.9f026fd5-f996-4383-b528-841d38d3dab52026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.c5e52ddd-a909-487a-bb46-01ad356906652026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075927
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.65b892f2-8385-4bb0-8121-a58b01e8d13d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LPcfd4ef00-cfc4-4794-99fe-faa45eb2f6172026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENHAWAII REPACK, INC.888efc91-b4de-4691-b84c-fb871e7a6dfe2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENSt. Mary's Medical Park Pharmacye3a3e5d2-2d1e-74d3-e053-2995a90a82bf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENCoupler LLC545fe39a-4777-b149-e063-6394a90a53cf2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENCoupler LLC53e6519a-cb52-85e2-e063-6394a90abdcf2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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