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 |
|---|---|---|---|---|---|---|
| MIMIBO PREMIUM TOOTH | SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE | CONE MEDICAL Co., Ltd. | c101881a-5a12-2e04-e053-2a95a90a3f57 | 2025-01-02 | Warnings | ETJ7Z6XBU4 |
| NativeRemedies Acid Free-Flux | CALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9X | Silver Star Brands | d5012b1f-861e-40b8-e053-2a95a90a4fe2 | 2025-01-01 | Warnings | ETJ7Z6XBU4 |
| Mucus Clear Allergy Relief | ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA | Silver Star Brands | f49bdcc1-1939-6dc2-e053-2995a90a0a3b | 2025-01-01 | Warnings | ETJ7Z6XBU4 |
| NativeRemedies Gout-Gone | ANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEA | Silver Star Brands | f66b42f0-8f5f-1aca-e053-2a95a90ae396 | 2025-01-01 | Warnings | ETJ7Z6XBU4 |
| NeuropathEase | AGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEA | Silver Star Brands | 7809e54a-018d-9cf6-e053-2a91aa0aedfe | 2025-01-01 | Warnings | ETJ7Z6XBU4 |
| AllergiClear-M | ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA | Silver Star Brands | 9d36096b-022f-5cfa-e053-2995a90a381f | 2025-01-01 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | b33c534d-4fa3-0a2f-e053-2995a90ab52f | 2024-12-31 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | b33c4164-e607-2e27-e053-2a95a90ad7db | 2024-12-31 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | b4f2f888-979a-6f54-e053-2a95a90a95a3 | 2024-12-31 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a1884-f46f-5cd4-e053-2a95a90a3e27 | 2024-12-31 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a9d82-1d61-aeec-e053-2995a90a03a4 | 2024-12-31 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | ec09736a-dd2b-0a3b-e053-2995a90a9542 | 2024-12-31 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2a58145a-57f9-6bb1-e063-6294a90a32a8 | 2024-12-29 | Warnings, Adverse reactions | ANDA214099 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2a586399-49e9-1e5c-e063-6294a90a4872 | 2024-12-28 | Warnings, Adverse reactions | ANDA214099 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | 29987a4c-cf5f-4f98-e063-6394a90a7f19 | 2024-12-19 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Trace Mineral Cord | ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM, | Energique, Inc. | 902dd68d-5ce1-481e-8938-6487dcc68dfc | 2024-12-19 | Warnings | ETJ7Z6XBU4 |
| BACLOFEN | BACLOFEN | Quality Care Products, LLC | 67df80a6-7fff-496e-9a89-d43a06c2a11f | 2024-12-19 | Warnings, Adverse reactions | ANDA214099 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7b6d33d8-58c2-448d-a8df-1de7339b1520 | 2024-12-12 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4cbb2264-ef65-4906-86e5-349deeeda7a9 | 2024-12-05 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 32525b4e-6384-49e1-a66d-abe45484ab86 | 2024-12-05 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.