NDC 85534-0063-01 - Ondansetron
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
- 85534-0063
- Requested NDC
- 85534-0063-01
- Package NDCs from labels
- 85534-0063-0, 85534-0063-1, 85534-0063-2, 85534-0063-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-07-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ondansetron - HAWAII REPACK, INC. | HAWAII REPACK, INC. | 2026-07-17 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Cloveden Vegan Whitening Tooth | SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE | DONG IL PHARMS CO.,LTD | 3fb16579-7cf1-873a-e063-6294a90a9ac1 | 2025-09-26 | Warnings | ETJ7Z6XBU4 |
| Vax-Sode | THUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA | Nutritional Specialties, Inc. | cd570e98-c73f-4b38-b5b9-9f16f745ca19 | 2025-09-22 | Warnings | ETJ7Z6XBU4 |
| Libido | HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIA | Newton Laboratories, Inc. | 9c334fbd-0c1e-eac0-e053-2995a90a9283 | 2025-09-19 | Warnings | ETJ7Z6XBU4 |
| Libido | HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIA | Newton Laboratories, Inc. | 9c348fa7-1d68-4975-e053-2995a90a0ca6 | 2025-09-19 | Warnings | ETJ7Z6XBU4 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 9558d296-8edd-4aa1-875a-6247f9a8374d | 2025-09-15 | Warnings, Adverse reactions | ANDA090469 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 10afd68b-877f-4819-a314-39f2d56d5db9 | 2025-09-15 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| Owell Naturals Draw Salve, Arnica, Silicea | ARNICA MONTANA HPUS, SILICEA HPUS | Owell Naturals Brand LLC | 1c9dab31-de1f-911b-e063-6294a90a0391 | 2025-09-12 | Warnings | ETJ7Z6XBU4 |
| Owell Naturals Draw Salve | ARNICA MONTANA HPUS, SILICEA HPUS | Owell Naturals Brand LLC | 1536ff1e-16b8-fbbc-e063-6394a90a628e | 2025-09-12 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb 12 General Tonic | CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | Martin & Pleasance Pty Ltd | 9083a01b-2fbe-4e04-9eec-bf4f65950ec7 | 2025-09-09 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb 12 General Tonic | CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | Martin & Pleasance Pty Ltd | c14c79ab-85bb-45f2-83d1-1d9c298ffdfd | 2025-09-08 | Warnings | ETJ7Z6XBU4 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 2025-09-04 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Allergy and Sinus Relief | PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE | Schwabe North American, Inc. | c90cc6f5-14ec-41a3-a20a-4e8018bb02fb | 2025-08-25 | Warnings | ETJ7Z6XBU4 |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2025-08-21 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| Aurum Hypericum | AURUM HYPERICUM | Uriel Pharmacy Inc. | 0c3ed6fe-8dce-0496-e063-6394a90add56 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 93e05175-001b-c639-e053-2a95a90a289c | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 9b4276af-b738-3293-e053-2a95a90ad022 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 617303f8-4463-4a1e-a502-44abc181d91f | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 03153d92-dc68-4b84-a8c9-634b1ffd7da1 | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Cloveden Vegan Whitening Tooth | SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE | Acuseplanet Inc | 3c04778b-9535-856e-e063-6294a90aa868 | 2025-08-10 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.