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 |
|---|---|---|---|---|---|---|
| Supreme | ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA | BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE | 72c4679b-aa97-4888-9178-581d0f99c0b6 | 2020-09-11 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | 9edc00c6-c281-4e81-b176-44b7536f71f2 | 2020-08-13 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | d9e5a8b9-1524-41b4-942f-f95015dd17f9 | 2020-08-05 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Proficient Rx LP | 924a01fb-0ed0-4f73-9304-d6c5b9961d66 | 2020-05-01 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Teva Pharmaceuticals USA, Inc. | 5648c772-50cb-4961-996e-e68a8eb699ea | 2019-12-31 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| Sinus Relief | ASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUM | Homeocare Laboratories | 84483171-df92-47de-9203-ed02d64fb5fb | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| Hair-X Hair Loss Relief | CADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDIS | Homeocare Laboratories | 00b62179-e03b-4972-902d-3a0c969b59bc | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| GUNA-SINUS NOSE | ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER - | Guna spa | 36fef678-17c6-4d2a-a0f0-ddb298611f25 | 2018-12-22 | Warnings | ETJ7Z6XBU4 |
| Gastrozen | COFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM AC | Natural Creations, Inc | 98dd756f-6774-47c3-bdfb-deff82fb801d | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Runny Nose CP | ALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHUR | Natural Creations, Inc | 868ec0ad-9344-4f94-b2c1-2abb48479b15 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Mold Antigen | ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC | Zorex International | ff92e909-b5a7-417f-98a4-551f1576fd1e | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Nausea CP | AETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHUR | Natural Creations, Inc | 2746cde1-577b-41d6-9f22-93d8f1a2c235 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Hydrate II | BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA | Zorex International | e5f53495-3b75-4d7c-89af-23058fb6fd05 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Dust Mix Antigen | ANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUS | Natural Creations, Inc | 8dab4b4a-6fa8-4258-adc1-f8c634e2030b | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| HA HP | BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA | BioActive Nutritional, Inc. | 30f6c191-ce6e-438c-9601-74f5e8b61f96 | 2018-07-06 | Warnings | ETJ7Z6XBU4 |
| Immuno Fortifier | ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEA | BioActive Nutritional, Inc. | 04024663-0b11-438a-a21a-8e86edd8052a | 2018-01-15 | Warnings | ETJ7Z6XBU4 |
| H-Acne Formula | CALENDULA OFFICINALIS, NUX VOMICA, SILICEA | Healing Natural Oils LLC | fd9598ac-8f69-4fba-99c1-4234c8afcafd | 2017-12-27 | Warnings | ETJ7Z6XBU4 |
| H-Nail Fungus Formula | CALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALIS | Healing Natural Oils LLC | 68f87ae5-fa3a-45cf-971c-c09e98106dd8 | 2017-12-27 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | dd4b9972-0295-4555-a90b-bb087170cfbb | 2017-12-07 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.