FDA.reportPublic FDA data

NDC 69837-170-02 - 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
69837-170-02
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 1 of 193 · 3,852 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSREMEDYREPACK INC.9e041905-40a7-4d5b-af1c-6c544e0748b92026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 577208
unii: D87YGH4Z0Q
omega-3-acid ethyl estersOMEGA-3-ACID ETHYL ESTERSStrides Pharma Science Limited9499c40e-6665-4fbf-914d-1a9931b935622026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 577208
unii: D87YGH4Z0Q
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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