FDA.reportPublic FDA data

NDC 65862-0071-01 - Amoxicillin

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
65862-0071
Requested NDC
65862-0071-01
Package NDCs from labels
65862-0071-01
Manufacturer
Dispensing Solutions Inc.
Effective date
2009-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AmoxicillinDispensing Solutions Inc.2009-10-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2

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.

Matched openFDA labels page 29 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.05b9b595-05d9-469f-82a3-c2bc94c50be22025-01-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINRedpharm Drugfc61c9f5-b0f8-3ff8-e053-6394a90adeb72025-01-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 1Q73Q2JULR
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Amoxicillin/Clav Pot Oral SuspAMOXICILLIN/CLAV POT ORAL SUSPDirect_Rxe5bd9918-b073-c50b-e053-2a95a90aaeb72025-01-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxilAMOXICILLIN ORAL SUSPDirectRxec7dd735-dc92-3d29-e053-2a95a90af5492025-01-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINDirect_Rxf98c49a3-e6bb-7fc7-e053-6394a90a90622025-01-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxcdc6d30a-754e-6672-e053-2a95a90afa7f2025-01-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINDirectRxcedde8f5-aadd-53de-e053-2995a90aab162025-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA065334
rxcui: 308189
unii: 804826J2HU
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.2bb03d3b-5d44-bc4a-e063-6394a90a656a2025-01-14Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-33ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINCDNA Labs, Inc.26f9bf6d-6038-42e8-b8c1-6c94ac4929af2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.