Home DailyMed bbf3a739-13d7-4667-e053-2a95a90a1eca Baclofen Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Central Packaging | Central Packaging, LLC
Effective date 2021-02-22
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 20:35:38 Label at a glance# Product Baclofen
Active ingredient BACLOFEN
Label structure 2 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 197391 baclofen 10 MG Oral Tablet PSN 1 197391 baclofen 10 MG Oral Tablet SCD 1
DailyMed Pharmacologic Classes# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80175-0006-3 Baclofen 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80175-0006 BACLOFEN TABLET [CENTRAL PACKAGING] 1 Legacy NDC, 1 package rows 20210223_bbf3a739-13d7-4667-e053-2a95a90a1eca.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 1 matching rows.
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 1 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211555-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2019-02-01 A211555-002 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2019-02-01 A211555-003 BACLOFEN BACLOFEN 5MG TABLET / ORAL AB 2021-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 120 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A211555-001 BACLOFEN 10MG TABLET / ORAL AB 2019-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211555-002 BACLOFEN 20MG TABLET / ORAL AB 2019-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211555-003 BACLOFEN 5MG TABLET / ORAL AB 2021-11-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211555-001 BACLOFEN 10MG TABLET / ORAL AB 2019-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211555-002 BACLOFEN 20MG TABLET / ORAL AB 2019-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211555-003 BACLOFEN 5MG TABLET / ORAL AB 2021-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211555-002 BACLOFEN 20MG TABLET / ORAL BX 2019-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211555-003 BACLOFEN 5MG TABLET / ORAL BX 2021-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211555-001 BACLOFEN 10MG TABLET / ORAL BX 2019-02-01 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
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.
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Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
