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 |
|---|---|---|---|---|---|---|
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b59731a2-c775-7e8a-e053-2a95a90a9062 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Acne - Cystic Acne | ECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEA | Newton Laboratories, Inc | 92afe017-74c7-16c6-e053-2995a90a5c7d | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Breast Care - Fibrocystic | BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM | Newton Laboratories, Inc. | 98d01128-9887-12ce-e053-2a95a90a7329 | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b56f2ffc-4637-1f23-e053-2a95a90aa3af | 2020-12-01 | Warnings | ETJ7Z6XBU4 |
| Hair-Scalp | APIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC. | Newton Laboratories, Inc. | 9ab3b944-443c-74a1-e053-2a95a90aa0e5 | 2020-11-30 | Warnings | ETJ7Z6XBU4 |
| Acne | ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM | Newton Laboratories, Inc. | 798c853c-16ab-8502-e053-2a91aa0a6532 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Acne | ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM | Newton Laboratories, Inc. | 798d5f34-819a-9895-e053-2991aa0a1d62 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Breast Care | BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM | Newton Laboratories, Inc. | 79edde91-f909-f7b3-e053-2991aa0a9d1c | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM | Newton Laboratories, Inc. | 90807700-3099-850c-e053-2995a90ada55 | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM | Newton Laboratories, Inc. | 90804a94-1e67-3ab3-e053-2a95a90aafbe | 2020-11-24 | Warnings | ETJ7Z6XBU4 |
| Post - Vaccination | INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM | Newton Laboratories, Inc. | 9042b7ad-15ed-0e81-e053-2a95a90afe28 | 2020-11-23 | Warnings | ETJ7Z6XBU4 |
| Post-Vaccination | INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM | Newton Laboratories, Inc. | 90bb15e5-3d9d-e2e2-e053-2995a90a85ac | 2020-11-23 | Warnings | ETJ7Z6XBU4 |
| GUNA MATRIX DETOX | SODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS - | Guna spa | a369b95b-4d57-f149-e053-2995a90a87e3 | 2020-10-23 | Warnings, Adverse reactions | ETJ7Z6XBU4 |
| Supreme | ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA | BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE | 72c4679b-aa97-4888-9178-581d0f99c0b6 | 2020-09-11 | Warnings | ETJ7Z6XBU4 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Asclemed USA, Inc. | bf29327f-4e43-4597-83d2-f64349bf9d9a | 2020-09-01 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | ead1e453-af08-4a3b-8379-aa182dff514b | 2020-09-01 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 7974a666-6d1d-446b-8ea5-f7145dc66358 | 2020-02-01 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | 4655e0ea-f7d5-4f7c-bf7b-266337bc05b8 | 2019-11-01 | Warnings, Adverse reactions | 617430 804826J2HU |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 586a5911-e30b-40ed-a056-9e67920ca951 | 2019-11-01 | Warnings, Adverse reactions | 804826J2HU |
| amoxicillin and clavulanate potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | 1f252ad3-373c-4a6d-96e7-53ba820d201b | 2019-11-01 | Warnings, Adverse reactions | 617430 Q42OMW3AT8 804826J2HU |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.