BACLOFEN - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2019-12-17
Label type: Indexing - product concept
Version: 3
Source: full-release
Hydrated at: 2026-06-05 00:18:37

Label at a glance#

ProductBACLOFEN

Active ingredientBACLOFEN

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

BACLOFEN

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BACLOFEN	H789N3FKE8	ACTIB

Source Document#

Source XML

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 9 · 167 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ab3760cd-a84b-49ba-88e3-b9ea73c55f82	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Atlantic Biologicals Corp.	50b3e7be-832b-313d-e063-6394a90a5ab4	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	4e2cd27d-91c7-4f15-96cc-3971769dbeaa	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	c2e1d183-7061-459b-a631-206b06d12753	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Par Health USA, LLC	c17527be-661d-42f5-b6f6-56a681ba7870	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	aeb56b0e-7126-4417-b726-e8a54f73de3f	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ac9b720f-b755-49f1-9850-efb26feadaeb	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	355266e4-68f7-47d7-9f4e-1a0fc912786d	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	76896b07-2835-4467-b386-87ec66ddd88e	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Cardinal Health 107, LLC	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	3047613d-006b-4011-b5fe-098588f474aa	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	6274e70a-fb57-461b-b1bc-39d4ff916b2a	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals, Inc.	2517f71f-f452-1f56-e063-6394a90a6ef1	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Redpharm Drug	53df4b4b-842e-9e3a-e063-6394a90a8a3d	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	d689d32c-12a7-4ae4-afc3-8a353be67148	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Eywa Pharma Inc	7ec59f6b-7c4f-432d-ba27-442861806b6c	2026-05-16	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	e017a001-8cb1-4dd8-960e-c6d74005f57f	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	AvPAK	bc9040d9-1c54-9d62-e053-2a95a90a6ae3	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN

Reported adverse events (FAERS/openFDA)#

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