NDC 85534-0004-01 - 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
- 85534-0004
- Requested NDC
- 85534-0004-01
- Package NDCs from labels
- 85534-0004-1, 85534-0004-3, 85534-0004-6, 85534-0004-9, 85534-0004-0, 85534-0004-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2025-06-11
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Baclofen Tablets USP Rx only | HAWAII REPACK, INC. | 2025-06-11 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85534-0004-0 | BACLOFEN | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 85534-0004-1 | BACLOFEN | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 85534-0004-3 | BACLOFEN | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 85534-0004-6 | BACLOFEN | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 85534-0004-9 | BACLOFEN | 90 in 1 BOTTLE | TABLET | 90 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 540e4ee3-596f-4cea-e063-6294a90a6a60 | 2026-06-12 | Warnings | ETJ7Z6XBU4 |
| Jacksons Cell Salts SKIN BALANCE | CALC SULPH, KALI SULPH, SILICEA | Zettl Health Inc. | 54012f03-4c34-42f5-e063-6394a90aacc5 | 2026-06-11 | Warnings | ETJ7Z6XBU4 |
| BACLOFEN | BACLOFEN | Redpharm Drug | 53df4b4b-842e-9e3a-e063-6394a90a8a3d | 2026-06-10 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | BM Private Limited | 53e763ee-9a44-a914-e063-6394a90aeb3c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| GUNA-AWARENESS | BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - | Guna spa | 10e46b39-7903-4390-b72d-865291245b4c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d3c1d6-d0ba-5ea7-e063-6394a90a0294 | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| BM Silicea | SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53bb3927-6053-eb3d-e063-6394a90a5ddf | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Scrofularoforce | RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA | BioActive Nutritional, Inc. | 737cd410-0405-41b0-b7f2-29bb20037849 | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| VAX | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, | BioActive Nutritional, Inc. | faa4a678-321a-4982-a5d4-01b713e6862d | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Vermex | ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM | BioActive Nutritional, Inc. | 6be5fbcf-bb22-4b20-b65a-d943c516adf9 | 2026-06-04 | Warnings | ETJ7Z6XBU4 |
| BM Silicea Icing Sugar | SILICEA ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 535ba100-627f-36b4-e063-6394a90a3373 | 2026-06-03 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | d689d32c-12a7-4ae4-afc3-8a353be67148 | 2026-06-01 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | BM Private Limited | 5331dc40-2ac8-5fce-e063-6394a90a5875 | 2026-06-01 | Warnings | ETJ7Z6XBU4 |
| Dentaforce | ANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUM | BioActive Nutritional, Inc. | 82321547-e04a-42ff-aa39-6a192638e5a2 | 2026-05-18 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Eywa Pharma Inc | 7ec59f6b-7c4f-432d-ba27-442861806b6c | 2026-05-16 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| C07 STRONG LIGAMENTS AND JOINTS | ARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALE | Apex Energetics Inc. | bccf8c83-a6cd-e58c-e053-2a95a90a43d7 | 2026-05-13 | Warnings | ETJ7Z6XBU4 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | e017a001-8cb1-4dd8-960e-c6d74005f57f | 2026-05-12 | Warnings, Adverse reactions | H789N3FKE8 |
| Acne Relief | BELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHUR | NaturalCare | 487b1373-b78c-4510-964a-6ab0fe781ff4 | 2026-05-08 | Warnings | ETJ7Z6XBU4 |
| Gablofen | BACLOFEN INJECTION | Piramal Critical Care Inc | 00d3e846-dd92-448d-9ab8-6a07be823cc1 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.