FDA.reportPublic FDA data

OMEGA-3-ACID ETHYL ESTERS - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2024-12-18
Label type
Indexing - product concept
Version
9
Source
full-release
Hydrated at
2026-06-05 00:24:21

Label at a glance#

ProductOMEGA-3-ACID ETHYL ESTERS
Active ingredientOMEGA-3-ACID ETHYL ESTERS

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
OMEGA-3-ACID ETHYL ESTERSD87YGH4Z0QACTIB

Source Document#

Source XML

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 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.9e041905-40a7-4d5b-af1c-6c544e0748b92026-09-03Warnings, Adverse reactionsName fallback
brand name: Omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSStrides Pharma Science Limited9499c40e-6665-4fbf-914d-1a9931b935622026-09-02Warnings, Adverse reactionsName fallback
brand name: omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSMajor Pharmaceuticalse40d55f2-db9f-4a48-8639-9aa7491e4de52026-05-21Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSCamber Pharmaceuticals, Inc.0d842966-26bc-4521-b401-635a836180122026-04-30Warnings, Adverse reactionsName fallback
brand name: Omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSXLCare Pharmaceuticals, Inc.18947318-31b4-42fb-83be-8f1bfe732e952026-04-30Warnings, Adverse reactionsName fallback
brand name: Omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee2026-04-27Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-Acid Ethyl EstersOMEGA-3-ACID ETHYL ESTERSGolden State Medical Supply, Inc.11d744aa-cc06-1206-e063-6294a90a49c92026-04-06Warnings, Adverse reactionsName fallback
brand name: Omega-3-Acid Ethyl Esters
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSLifestar Pharma LLC769ad170-5d70-4a54-995a-fef95ef503eb2026-02-13Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions6fea8860-3c63-435f-a5b0-4281364ebd092026-01-20Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions4eef8b47-8185-4d93-9b2a-1200b953a6e32026-01-20Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSChartwell RX, LLC331d5d9d-58d8-4b4f-8114-b28efa7276d72025-12-22Warnings, Adverse reactionsName fallback
brand name: omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSAmerican Health Packaging294ee73f-849c-4c3d-a415-d66138c91f532025-04-29Warnings, Adverse reactionsName fallback
brand name: omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-Acid Ethyl EstersOMEGA-3-ACID ETHYL ESTERSKD Pharma USA, Inc.d1fd2a28-befb-4a09-b516-0c01bc4c8c6c2025-02-10Warnings, Adverse reactionsName fallback
brand name: Omega-3-Acid Ethyl Esters
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSKD Pharma USA, Inc.5cf3091e-4a88-4799-a88a-d53a5bc1de572025-02-10Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS52d4fc86-227a-4a74-9f42-50fd184714d82025-01-08Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSEPIC PHARMA, LLC787f9929-ef31-42a7-a305-8ba343e396722025-01-07Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepack7d75287f-6f09-43b0-9b38-150685236d472024-12-27Warnings, Adverse reactionsName fallback
brand name: Omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSNCS HealthCare of KY, LLC dba Vangard Labsc293de7f-b4b6-461b-a0eb-470e5b84618d2024-10-18Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSBryant Ranch Prepackc8dc6c4a-ed19-4727-ba5a-35075f1ddddf2024-08-08Warnings, Adverse reactionsName fallback
brand name: OMEGA-3-ACID ETHYL ESTERS
generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSA-S Medication Solutions730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa2024-02-18Warnings, Adverse reactionsName fallback
brand name: Omega-3-acid ethyl esters
generic name: OMEGA-3-ACID ETHYL ESTERS

Reported adverse events (FAERS/openFDA)#

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