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 |
|---|---|---|---|---|---|---|
| Baclofen | BACLOFEN | Direct_rx | 1bf59c3b-f8eb-972e-e063-6394a90aeccc | 2024-06-28 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Argentum Quartz 6X | ARGENTUM QUARTZ 6X | True Botanica, LLC | 1acadf89-d222-9e16-e063-6294a90a80bc | 2024-06-26 | Warnings | ETJ7Z6XBU4 |
| Cold Sore Rescue | BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA | Peaceful Mountain, Inc. | a7fe6ec7-a758-43cf-b46f-c327e0632fb8 | 2024-06-13 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICEA | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 1a361030-a925-0998-e063-6394a90a915d | 2024-06-06 | Warnings | ETJ7Z6XBU4 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 9834e409-8633-4f99-8ac7-7fa298d01c44 | 2024-05-30 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | 19b049cf-56a4-aeaa-e063-6394a90a366d | 2024-05-30 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | adc072b9-e48b-470d-9eb1-fd7b52c1f122 | 2024-05-29 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Multiple Miasm | ACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 92c97bf6-8dd9-43a9-b686-75420b029197 | 2024-05-21 | Warnings | ETJ7Z6XBU4 |
| Osteopar | EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVA | Energique, Inc. | 6c346a26-26a2-4be0-b8a3-bbb5709bcf3d | 2024-05-21 | Warnings | ETJ7Z6XBU4 |
| Colopar | COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS | Energique, Inc. | c47d7203-abcd-4ae5-bf9b-5df07e07d3c1 | 2024-05-20 | Warnings | ETJ7Z6XBU4 |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | 4510fe59-cc28-4585-925f-42508a60abd0 | 2024-05-13 | Warnings | ETJ7Z6XBU4 |
| EMF Protect and Balance | ALFALFA, FUCUS VESICULOSUS, KALI PHOSPHORICUM, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, FERRUM METALLICUM, CADMIUM SULPHURATUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, YTTERBIUM OXIDE, TARENTULA CUBENSIS, X-RAY, CUPRUM METALLICUM, SILICEA | Deseret Biologicals, Inc. | df7e925e-00d1-4b0c-8a78-ad38148bc360 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Multiple Miasm | ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SULPHUR, ALOE, CARCINOSIN, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 0cf54ec3-d731-4f27-89fd-4571d991a615 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Osteopar | EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVA | Energique, Inc. | daf83dbf-bbf4-49e2-ade1-1d86f3e52675 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Occuloplex I | EUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENE | BioActive Nutritional, Inc. | c2c9b577-4f75-4ddc-815f-46c3bb9b46d2 | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| Lymphoplus | TRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA | Deseret Biologicals, Inc. | 92f6fc6b-58c0-4137-88b3-bee2118aeb29 | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | a1b42f4b-4029-4008-b950-a7725f34b43d | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | 04dfad30-9496-43c6-8ce8-ab04fdb9ce3b | 2024-05-06 | Warnings | ETJ7Z6XBU4 |
| AI Miasm | ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUM | Energique, Inc. | df829e4a-c982-4d02-b318-38b1fbc5072d | 2024-05-02 | Warnings | ETJ7Z6XBU4 |
| VACC HC | HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM | Deseret Biologicals, Inc. | a98082ba-21ec-4cf8-b81c-bcb41eb9fd12 | 2024-04-23 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.