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 |
|---|---|---|---|---|---|---|
| Teething-Colic | CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE | Newton Laboratories, Inc. | 9db4790e-28c2-2dce-e053-2a95a90ae792 | 2025-11-06 | Warnings | ETJ7Z6XBU4 |
| Ondansetron | ONDANSETRON | Proficient Rx LP | 81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74 | 2025-11-01 | Warnings, Adverse reactions | 312087 104894 4AF302ESOS |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| ondansetron | ONDANSETRON | Accord Healthcare, Inc. | 35e0d160-813f-41d7-a382-d2cab6485d9c | 2025-10-29 | Warnings, Adverse reactions | 4AF302ESOS |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and Teeth | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA | MIRANDA CASTRO'S SHOP, LLC | 267fb775-a03c-f100-e063-6394a90aa826 | 2025-10-23 | Warnings | ETJ7Z6XBU4 |
| Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA | MIRANDA CASTRO'S SHOP, LLC | 266e907b-4cdb-fb4f-e063-6394a90aa434 | 2025-10-23 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO PEACH MINT WHITENING TOOTH | HYDROGEN PEROXIDE, SILICA | ATOSAFE CO., Ltd | 41196c2f-8e2e-a54d-e063-6294a90ad8a7 | 2025-10-14 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO PEACH MINT WHITENING TOOTH | HYDROGEN PEROXIDE, SILICA | DONG IL PHARMS CO.,LTD | 41198822-7c8f-ceb2-e063-6394a90a4373 | 2025-10-14 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO ORIGINAL TOOTH | SILICA, SODIUM MONOFLUOROPHOSPHATE | DONG IL PHARMS CO.,LTD | 41197bb6-f6f4-c86d-e063-6294a90ad476 | 2025-10-14 | Warnings | ETJ7Z6XBU4 |
| Ondansetron | ONDANSETRON | Lifsa Drugs LLC | c66d63cf-a0e5-4cb5-bdf8-9d1115cba23e | 2025-10-13 | Warnings, Adverse reactions | 4AF302ESOS |
| DENTI BUONGIORNO ORIGINAL TOOTH | SILICA, SODIUM MONOFLUOROPHOSPHATE | ATOSAFE CO., Ltd | 4114ab09-1115-6b0b-e063-6394a90ab442 | 2025-10-13 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO PLAQUE CARE TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATE | ATOSAFE CO., Ltd | 41155922-d7ac-0a7a-e063-6294a90afe48 | 2025-10-13 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO PLAQUE CARE TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATE | DONG IL PHARMS CO.,LTD | 41157552-2473-176b-e063-6294a90a9ad0 | 2025-10-13 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO GUM CARE TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE | ATOSAFE CO., Ltd | 4115d122-3090-d3e5-e063-6294a90aafb6 | 2025-10-13 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO GUM CARE TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE | DONG IL PHARMS CO.,LTD | 4115b653-63ff-703f-e063-6294a90a652a | 2025-10-13 | Warnings | ETJ7Z6XBU4 |
| Silicea Belladonna | SILICEA BELLADONNA | Uriel Pharmacy Inc. | a142eb87-c5fb-4138-bc98-e7f1391fe221 | 2025-10-10 | Warnings | ETJ7Z6XBU4 |
| Parathyropar | SYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, RHUS TOX, SILICEA, PARATHORMONUM | Energique, Inc. | bd13617a-c470-4421-8f47-43a98036f40b | 2025-10-06 | Warnings | ETJ7Z6XBU4 |
| Mitochondria PRO | ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM, | Energique, Inc. | 8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad | 2025-10-06 | Warnings | ETJ7Z6XBU4 |
| Tri-Relief Antifungal | SODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIG | Forces of Nature | 6fe97b54-8aa3-4d86-9055-0629589a416b | 2025-10-06 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.