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 6 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	2025-11-24	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2	2025-11-12	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Northstar RxLLC	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	2025-11-05	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Major Pharmaceuticals	f328296e-0713-4acb-bcb5-c10d7838d380	2025-10-29	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
LACRIFRESH HYDRAPF	GLYCERIN, POVIDONE	AVIZOR, S.A.	41bbd23e-0ec8-eb18-e063-6294a90a46d1	2025-10-27	Warnings	Exact identifier unii: FZ989GH94E
LACRIFRESH HYDRAMAXPF	GLYCERIN, POVIDONE	AVIZOR, S.A.	41be1604-89b4-7ec3-e063-6294a90a3331	2025-10-27	Warnings	Exact identifier unii: FZ989GH94E
Stye	POLYVINYL ALCOHOL AND POVIDONE	Medtech Products Inc.	60c11d3d-df20-4d1c-b425-49a84fecea30	2025-10-23	Warnings	Exact identifier unii: FZ989GH94E
iVIZIA Dry Eye	POVIDONE	Thea Pharma Inc.	1ef73cb1-da48-a713-e063-6294a90afa9d	2025-10-20	Warnings	Exact identifier unii: FZ989GH94E
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	95755a7b-4a9f-45ea-a381-d3f661150efe	2025-10-20	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	5cba5255-e5ad-48fd-8385-60e9ea6b6407	2025-10-09	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	0a5940cd-63eb-4d1b-8e92-44df264bc05a	2025-10-03	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	ab5fd609-3081-4400-90cd-c83b6834d381	2025-10-03	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Marlex Pharmaceuticals Inc	1b0f50c8-62e3-414d-96d3-5fd16e8043ab	2025-09-22	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Eyes Irritation Relief	POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	bd2608c6-ffdf-352a-e053-2995a90a26a8	2025-09-12	Warnings	Exact identifier unii: FZ989GH94E
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	844a09ab-6c11-44fa-a09b-09e2b7a3759e	2025-08-25	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	35bccefe-8d2e-85b5-e063-6394a90a58ca	2025-08-13	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	American Health Packaging	8b046ee6-28fc-4ab1-b543-414ad0103e5c	2025-08-04	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Method Pharmaceuticals LLC	1a9db542-d2b0-141a-e063-6394a90acc11	2025-07-23	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Trifluent Pharma, LLC	890df151-f4eb-4244-97c4-f1f10912e753	2025-07-21	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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