NDC 85534-0080-01 - Amoxicillin and Clavulanate Potassium
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
- 85534-0080
- Requested NDC
- 85534-0080-01
- Package NDCs from labels
- 85534-0080-0, 85534-0080-1, 85534-0080-2, 85534-0080-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-07-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Amoxicillin and Clavulanate Potassium - HAWAII REPACK, INC. | HAWAII REPACK, INC. | 2026-07-13 | 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 |
|---|---|---|---|---|---|---|
| DENTI BUONGIORNO ORIGINAL TOOTH | SILICA, SODIUM MONOFLUOROPHOSPHATE | DONG IL PHARMS CO.,LTD | 41197bb6-f6f4-c86d-e063-6294a90ad476 | 2025-10-14 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 0425932a-f6e1-49a6-8480-720f179ace14 | 2025-10-14 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| 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 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 98e9274c-c02e-44d9-8cc5-17536ef03a77 | 2025-10-10 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | b397d4be-d2ef-419a-98ac-844069c99d56 | 2025-10-08 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 9015d3dc-1ab4-2582-e053-2995a90a1679 | 2025-10-07 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| 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 |
| Kidnex IV | GINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS- | Energique, Inc. | 121eb51a-befe-47ea-85c6-d77e8c7e5864 | 2025-10-06 | Warnings | AB6MNQ6J6L |
| 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 |
| Cloveden Vegan Whitening Tooth | SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE | DONG IL PHARMS CO.,LTD | 3fb16579-7cf1-873a-e063-6294a90a9ac1 | 2025-09-26 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 924a9ef6-5e3d-4e78-ae97-ae090f6613c0 | 2025-09-24 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.