NDC 0591-5731 - 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: 0591-5731
Package NDCs from labels: 0591-5731-01, 0591-5731-05
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
Label	Manufacturer	Effective date	Type
Baclofen - Med Health Pharma, LLC	Med Health Pharma, LLC	2011-01-01	HUMAN PRESCRIPTION DRUG LABEL
BACLOFEN - STAT RX USA LLC	STAT RX USA LLC	2010-06-29	HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP 10mg & 20mg	Rebel Distributors Corp.	2009-12-01	HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP Revised: January 2004 Rx only	Watson Laboratories, Inc.	2007-01-08	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-5731-01	Bacolfen	100 in 1 BOTTLE	TABLET	100		3
0591-5731-05	Bacolfen	500 in 1 BOTTLE	TABLET	500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5731	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3	2 package rows	20070126_AADEE2AB-113B-4CD4-8184-575C3F496990.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
baclofen	ACTIVE MOIETY	H789N3FKE8	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Corn starch	INACTIVE INGREDIENT		BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Microcrystalline cellulose	INACTIVE INGREDIENT		BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Povidone	INACTIVE INGREDIENT		BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MED HEALTH PHARMA, LLC]	2
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MED HEALTH PHARMA, LLC]	2
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [STAT RX USA LLC]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [STAT RX USA LLC]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN 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 4 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Advagen Pharma Limited	04dac0f6-cc6c-4959-9bca-a6e4a99690f3	2026-01-23	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	69d0027a-cb46-4754-9225-071ec1ce4b37	2026-01-21	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	A-S Medication Solutions	975fda6d-d929-482b-8be7-60849026dbdd	2026-01-20	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Lotrimin Daily Sweat and Odor Control	TOPICAL STARCH	Bayer HealthCare LLC.	9ec5c80d-b550-496f-e053-2a95a90a5489	2026-01-16	Warnings	Exact identifier unii: O8232NY3SJ
Baclofen	BACLOFEN	Bryant Ranch Prepack	808113db-c5c2-404c-ab5f-62b991641cfe	2026-01-12	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Palmetto Pharmaceuticals Inc.	2422746c-afec-ad30-e063-6394a90a0403	2025-12-31	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
CVS Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	CVS Pharmacy, Inc.	f74a2fca-902c-f68a-e053-6394a90abb88	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Good Sense Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Geiss, Destin & Dunn, Inc.	9b243301-2e4b-5706-e053-2995a90a9b90	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Geiss, Derstin & Dunn, Inc.	9b34de99-13df-201a-e053-2a95a90ae559	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Publix Artificial Tears Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Publix Super Markets, Inc.	f5d1394b-0fe8-c372-e053-2a95a90a1f78	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Best Choice Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Best Choice	f5ba63f3-7966-81fe-e053-2995a90a342c	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Publix Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Publix Super Markets, Inc.	f7b0c3d6-0324-46c3-e053-6394a90a8241	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Kroger Eye Drops Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	The Kroger Company	f76f08c5-0111-8bc5-e053-6294a90a16ee	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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