FDA.reportPublic FDA data

amoxicillin 500 MG / clavulanate 125 MG Oral Tablet

RxCUI
617296
RxNorm name
amoxicillin 500 MG / clavulanate 125 MG Oral Tablet
Display name
amoxicillin 500 MG / clavulanate 125 MG Oral Tablet
Full name
amoxicillin 500 MG / clavulanate 125 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin/Clav PotAMOXICILLIN/CLAV POTDirect_Rx3b4f868d-6a3e-8276-e063-6294a90a64572026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 617296
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.6e1c6209-660f-4043-b6a6-eac5f7665ef92026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 617296
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMMicro Labs Limited0c2d1fbc-f80c-4737-a15e-9cfa6bf997692026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 617296
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMCoupler LLC513b6211-c73b-7e66-e063-6394a90a2aa12026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCfabeca32-3f26-4b65-b8b6-5f0e23765ab02026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAmerican Health Packaging4966a3f2-eed2-4081-ba88-310a3d1964b42026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.d23b6952-5e4c-4103-9fe0-a916b1e2e1b92026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 617296
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.56fb634c-3725-4d0a-8f20-584652a1d99f2026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC94b7c1bb-c024-4dc6-86d4-18a17a3eafcb2026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.48356a07-60b9-c844-e063-6394a90afafa2026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.f433611c-db72-af7f-e053-2995a90a4a702026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.ef2c7783-e419-288f-e053-2a95a90a628a2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.b509d0eb-fe01-4902-89ae-a0dc7f7c7f932025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack22cd4e96-2288-470c-9264-8058cd7db9b02025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 617296
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackb5e66987-09e3-45b2-88ba-59c8647d724e2025-10-23Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.cc445a39-d84c-4b76-9fb8-ae302e7cd96b2025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.0425932a-f6e1-49a6-8480-720f179ace142025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNorthStar Rx LLCd75b0a7e-cb9b-4102-bcac-097403b251292025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackf748b118-6d50-487a-824d-1c92ab2028c02025-07-29Warnings, Adverse reactionsExact identifier
rxcui: 617296
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsaf4c2ea8-73bd-429b-8392-fa20fec6fb3f2025-06-18Warnings, Adverse reactionsExact identifier
rxcui: 617296

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 62 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
94b7c1bb-c024-4dc6-86d4-18a17a3eafcbamoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]33These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420260204
b509d0eb-fe01-4902-89ae-a0dc7f7c7f93amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]33These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420251120
d567412a-e5ed-4c7f-90f0-ea3039786480amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]3320101122
fabeca32-3f26-4b65-b8b6-5f0e23765ab0amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420260424
f433611c-db72-af7f-e053-2995a90a4a70amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 198420260105
ef2c7783-e419-288f-e053-2a95a90a628aamoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 198420251211
d6f7619e-9476-91fa-e053-2995a90a8fedamoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, oral suspension and chewable tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate20241224
c565ca8c-b98e-4eb4-80ac-435e34aafe00amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS, USP These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS, USP safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS, USP. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420241010
a94cfba3-27ed-46a3-81ef-e9b80187c207amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to trea20240613
7dc856b1-0c46-94d6-e053-2991aa0aea16amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]32These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP and For Oral Suspension USP, for Oral Use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate pot20181224
513b6211-c73b-7e66-e063-6394a90a2aa1amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420260507
48356a07-60b9-c844-e063-6394a90afafaamoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420260112
3b4f868d-6a3e-8276-e063-6294a90a6457amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31Amoxicillin/Clav Pot20250801
266b5ec9-4159-b073-e063-6394a90aec62amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use AMOXICILLIN and CLAVULANATE POTASSIUM for oral suspension AMOXICILLIN and CLAVULANATE POTASSIUM chewable tablets, for oral use Initial U.S. Approval: 198420241108
d25c8190-3690-4ce6-a525-21850754224damoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420240930
1275ad58-c53f-20d0-e063-6394a90a4a43amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 198420240228
8c4125d4-d074-40d4-9def-d3a528fc8c8eamoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 198420230906
1c477549-1bbe-4065-b0f8-7514667755a3amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for Amoxicillin and Clavulanate potassium tablets, USP AMOXICILLIN and CLAVULANATE Potassium Tablets, USP for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be 20170123
cd4dbeda-4c11-4358-9479-7bdd02e56ad0amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only20120911
b34da4a3-f25e-46d3-b86a-7167d7546092amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only20120328
363c6f00-67cc-44b7-b51b-14f1fddf1bb2amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]3120110518
d0459c2a-2de1-4f19-acee-c1bd664f3342amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet [PSN] · amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [SCD] · amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet [SY]31AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only20090601