FDA.reportPublic FDA data

NDC 0591-5730 - Baclofen

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
0591-5730
Package NDCs from labels
0591-5730-01, 0591-5730-05
Manufacturer
Med Health Pharma, LLC
Effective date
2011-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Med Health Pharma, LLCMed Health Pharma, LLC2011-01-01HUMAN PRESCRIPTION DRUG LABEL
BACLOFEN - STAT RX USA LLCSTAT RX USA LLC2010-06-29HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP 10mg & 20mgRebel Distributors Corp.2009-12-01HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP Revised: January 2004 Rx onlyWatson Laboratories, Inc.2007-01-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5730-01Bacolfen100 in 1 BOTTLETABLET1003
0591-5730-05Bacolfen500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5730BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]32 package rows20070126_AADEE2AB-113B-4CD4-8184-575C3F496990.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BaclofenACTIVE INGREDIENTH789N3FKE8BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
baclofenACTIVE MOIETYH789N3FKE8BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
Corn starchINACTIVE INGREDIENTBACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
Magnesium stearateINACTIVE INGREDIENT70097M6I30BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
Microcrystalline celluloseINACTIVE INGREDIENTBACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
PovidoneINACTIVE INGREDIENTBACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]3
BaclofenACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [MED HEALTH PHARMA, LLC]2
BaclofenACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [MED HEALTH PHARMA, LLC]2
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [STAT RX USA LLC]1
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [STAT RX USA LLC]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBACLOFEN TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1

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 10 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENBryant Ranch Prepack80a4c6f7-4f02-493c-9263-62e1c90404ba2024-04-02Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
BACLOFENBACLOFENRising Pharma Holdings, Inc.6eb46715-d72b-473f-b984-90024033d4a02024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
BaclofenBACLOFENBryant Ranch Prepack7f27f935-b1fa-4494-9014-7f62c59bb8e32024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackfc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f2024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack402a0a2b-95a6-4d22-bedf-826e1f1cd2c32024-01-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackb4506087-be24-4e76-9fb8-b078051370722024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack54bea140-c537-44a2-8d1d-bfb20471f4d82024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepack12d57610-8c70-4729-b358-56525613a29d2024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb2024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: FZ989GH94E
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
unii: FZ989GH94E
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCc582972d-22ef-4326-b37f-adf2ca0b18752023-12-21Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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