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 | Bryant Ranch Prepack | f9c6d75a-a956-47b6-a5a2-deaf9797e2b2 | 2024-09-16 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 08a6866f-b127-482f-9f22-113175487bdd | 2024-09-12 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Chronagesic | ARNICA MONTANA, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, SANGUINARIA CANADENSIS, SULPHUR, PIPER NIGRUM, ALPHA-LIPOICUM ACIDUM, CARTILAGO SUIS, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS, APIOLUM | Deseret Biologicals, Inc. | 66e351ed-d359-4367-a950-fc57b37489ab | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| VACC HC | ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LAC FELINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM. | Deseret Biologicals, Inc. | a7536e3d-2cdb-49d7-9161-92ef64433883 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Focus | GINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGER | Deseret Biologicals, Inc. | e77857b8-be67-4041-8c8d-9772f17c6d06 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Mammaryplex | ECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE) | BioActive Nutritional, Inc. | 9c9ed6f6-8690-4fbd-8691-26dd577014a8 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 5b92b0a6-ebba-4815-8b94-f2014674399b | 2024-09-05 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Lymph Liquescence | ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ARSENICUM IODATUM, CURCUMA LONGA, SPLEEN (BOVINE), THYMUS (OVINE), CONIUM MACULATUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, SILICEA, ASTERIAS RUBENS, HYDRASTIS CANADENSIS, BUFO RANA | Nutritional Specialties, Inc. | 866ac8e1-431c-4c8b-b052-f6c4cff3769b | 2024-09-05 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4634093b-6def-41d6-a7f3-23040125c4f4 | 2024-09-03 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 655db2a3-daf7-4f4b-8f64-4a6d81fdc165 | 2024-09-03 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Geopathic Stress | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, SYMPHYTUM OFFICINALE, AGATE, CALCAREA CARBONICA, FERRUM METALLICUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, X-RAY, CUPRUM METALLICUM, TARENTULA HISPANA | BioActive Nutritional, Inc. | 7f4a18fc-1188-4201-85d5-f2d4d9d3fb7b | 2024-08-29 | Warnings | ETJ7Z6XBU4 |
| ASP | ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1) | BioActive Nutritional, Inc. | 66fe5457-fe15-4e33-b47e-2c0dc9b171f6 | 2024-08-28 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b5fde991-7d12-4083-a3d6-363718f1f6a1 | 2024-08-16 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f9df74a8-f225-44ca-91ba-dca4f3f35da0 | 2024-08-13 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Zydus Lifesciences Limited | bb5c6faa-2933-44d1-8706-8302150be734 | 2024-08-12 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Zydus Pharmaceuticals (USA) Inc. | cfc49176-8d01-4c39-9319-604dd087065c | 2024-08-12 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Mind Detox and Drainage | ALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUM | Deseret Biologicals, Inc. | 1ac1e955-a374-4cac-b997-51c6aef8d35d | 2024-08-01 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | NuCare Pharmaceuticals,Inc. | b2be2e6c-a247-30f4-e053-2a95a90a6ccb | 2024-07-17 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Terrestristat | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAY | Energique, Inc. | c3d2fd24-6b41-4c85-bd5f-c3306e97080e | 2024-07-03 | Warnings | ETJ7Z6XBU4 |
| Cough plus Bronchial | ANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENS | Liddell Laboratories, Inc. | 801eba42-4217-46e9-8f3e-745da01a27b0 | 2024-07-01 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.