FDA.reportPublic FDA data

NDC 69837-170-31 - OMEGA-3-ACID ETHYL ESTERS

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
69837-170
Requested NDC
69837-170-31
Package NDCs from labels
69837-170-31, 69837-170-30, 69837-170-05, 69837-170-02, 69837-170-03
Manufacturer
International Brand Management Inc
Effective date
2016-05-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OMEGA-3-ACID ETHYL ESTERS - International Brand Management IncInternational Brand Management Inc2016-05-05HUMAN PRESCRIPTION DRUG LABEL
Sure Result O3D3 System - International Brand Management, LLCInternational Brand Management, LLC2016-04-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69837-170-032020-01-31C16284748780-19d75b9d0-a3b1-f424-e053-dadaa90a57ceba854570-ad04-4960-b326-30a6beda89a8
69837-170-052020-01-31C16284748780-19d75b9d0-a3b1-f424-e053-dadaa90a57ceba854570-ad04-4960-b326-30a6beda89a8
69837-170-302020-01-31C16284748780-19d75b9d0-a3b1-f424-e053-dadaa90a57ceba854570-ad04-4960-b326-30a6beda89a8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-170-02OMEGA-3-ACID ETHYL ESTERS1 g in 1 CAPSULECAPSULE15
69837-170-03OMEGA-3-ACID ETHYL ESTERS30 in 1 BOTTLECAPSULE305
69837-170-05OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE1205
69837-170-30OMEGA-3-ACID ETHYL ESTERS30 in 1 BOTTLECAPSULE305
69837-170-31OMEGA-3-ACID ETHYL ESTERS1 g in 1 CAPSULECAPSULE15
69837-170-03Sure Result O3D3 System30 g in 1 BOTTLECAPSULE1 g1 g in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-170OMEGA-3-ACID ETHYL ESTERS CAPSULE [INTERNATIONAL BRAND MANAGEMENT INC]5Legacy NDC, 5 package rows20160506_ba854570-ad04-4960-b326-30a6beda89a8.zip
69837-170SURE RESULT O3D3 SYSTEM (OMEGA-3-ACID ETHYL ESTERS) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC20160418_fa9a1060-5d12-4d8e-9d39-5bf6fddc25b9.zip

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 2 of 193 · 3,852 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra Strength Gas ReliefSIMETHICONE ANTIGASKROGER COMPANY6aa691e4-3179-4cf7-855a-e44f16904c1c2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Infants Gas Relief Dye FreeSIMETHICONE ANTIGASTHE KROGER CO.722c8226-6556-4150-9fda-91be2b31183f2026-08-31WarningsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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