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 |
|---|---|---|---|---|---|---|
| Lymphoplex | MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA | BioActive Nutritional, Inc. | 624f35db-291e-4e7f-a2c9-ae319717157a | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Equisetum Silicea | EQUISETUM SILICEA | Uriel Pharmacy Inc. | e88b820b-4a07-42e2-8fe2-b30729e91a8c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| B Force HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA | BioActive Nutritional, Inc. | 811c6f32-fcad-464c-bcf6-ae6a59195b1c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Lymphdrainex | GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA, | Energique, Inc. | c512f211-f4f8-46f6-87ed-dd50287359df | 2026-03-27 | Warnings | ETJ7Z6XBU4 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | ee59a379-17d5-487f-b72f-a53e74744a70 | 2026-03-27 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 91175128-8285-4d04-89a9-219781be9260 | 2026-03-25 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 16266972-843e-4ea5-be1f-fb1b1588a5dc | 2026-03-25 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 0a1d09ac-94d5-45ef-92cc-bc261c2b2d75 | 2026-03-25 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| A plus Attention | BARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRA | NaturalCare | e77c2661-7ddf-4b09-b2e3-b9db3911011a | 2026-03-24 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 4f84b27a-725a-48e6-a58a-85bbb395f4ae | 2026-03-23 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | d20cc8b2-5236-4c87-b395-0acaaf7b62dd | 2026-03-19 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 5f6a86f9-9658-4210-a47c-62907edfd416 | 2026-03-19 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Nail Fungus Control | CALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDE | Forces of Nature | b7239e23-326e-4c1d-a080-55f457f1c454 | 2026-03-19 | Warnings | ETJ7Z6XBU4 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | 5e479876-adfb-4590-ac10-3924ff7988b0 | 2026-03-18 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | 3fdfeef9-68b3-4f6c-a4de-28179758a962 | 2026-03-18 | Warnings, Adverse reactions | ANDA214099 197391 H789N3FKE8 |
| Otoflam HP | BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLA | BioActive Nutritional, Inc. | 12f1ef62-93f3-45b8-885d-1b82f85a8355 | 2026-03-17 | Warnings | ETJ7Z6XBU4 |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | BM Private Limited | 4d269a3b-18ba-3ad2-e063-6294a90a1fae | 2026-03-16 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Redpharm Drug | 4ce1de84-72e1-57d3-e063-6294a90a220f | 2026-03-13 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| OZOBAX DS | BACLOFEN | Rosemont Pharmaceuticals LLC | d8ddcec5-debe-42b4-a803-e65917cc6a54 | 2026-03-13 | Warnings, Adverse reactions | H789N3FKE8 |
| Ligatone | ARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA | BioActive Nutritional, Inc. | 3a3bdd55-daec-43b9-a380-54a747fb7d10 | 2026-03-13 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.