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 5 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
BaclofenBACLOFENNorthwind Health Company, LLC06bcfb08-2ada-f803-e063-6394a90a826b2025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC459ec5f5-4f99-e917-e063-6294a90a23cd2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENWilshire Pharmaceuticals, Inc.4585aafe-0af8-4786-a419-6a7e76671ca22025-12-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
FLEQSUVYBACLOFENAzurity Pharmaceuticals, Inc.9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa2025-12-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENPHOENIX RX LLC45c6d45d-95d5-21b8-e063-6294a90a79552025-12-12Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENUpsher-Smith Laboratories, LLCb2747a9d-5fca-4657-9e4b-4112607f30d82025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENAdvagen Pharma Limitedd63af5f0-c275-480b-89b5-6cf1ad55ab632025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENSOLA Pharmaceuticals, LLC7b308b35-8c08-458d-860e-c78d057e82602025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENANI Pharmaceuticals, Inc.c73ed3af-8e8a-4a18-90fc-a0f2dcc641d02025-12-04Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENProficient Rx LP0680301a-1649-46c4-b74e-ab03967945d02025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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