FDA.reportPublic FDA data

NDC 60505-0102-01 - Etodolac

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
60505-0102
Requested NDC
60505-0102-01
Package NDCs from labels
60505-0102-1, 60505-0102-2, 60505-0102-01
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyApotex Corp. | Apotex Inc.2026-09-11HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyREMEDYREPACK INC.2026-06-09HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 500 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2026-05-05HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Bryant Ranch PrepackBryant Ranch Prepack2024-09-05HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyMedsource Pharmaceuticals | Apotex Inc.2024-03-05HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication SolutionsA-S Medication Solutions2023-12-10HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Proficient Rx LPProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Quality Care Products, LLCQuality Care Products, LLC2022-08-01HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC - DIRECT RXDIRECT RX2020-01-20HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyPreferred Pharmaceuticals Inc.2019-09-16HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC - DIRECT RXDIRECT RX2019-04-30HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Aidarex Pharmaceuticals LLC | Aidarex PharmaceuticalsAidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals2018-08-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0102-1Etodolac100 in 1 BOTTLETABLET, FILM COATED10016
60505-0102-2Etodolac500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0102ETODOLAC TABLET, FILM COATED [APOTEX CORP.]15Current NDC, Legacy NDC, 2 package rows20240809_4d682f98-1e8a-4c2b-6df3-169d2ed10dc1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0102-1EA - Each60505-01024b45057f-ad61-4cd5-9d3c-dbc1ec0f2c1012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [DIRECT RX]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, FILM COATED [DIRECT RX]1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, FILM COATED [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [DIRECT RX]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED [DIRECT RX]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [DIRECT RX]1
PovidoneINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, FILM COATED [DIRECT RX]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [DIRECT RX]1

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 35 of 112 · 2,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAY DEFENSE TINTEDTITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad4442-e45f-90e2-e063-6294a90aeef52025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d8b849-cf73-e008-e063-6394a90a410a2025-12-17Exact identifier
unii: 15FIX9V2JP
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
unii: 15FIX9V2JP
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b0ac77-13d8-4259-e063-6394a90a893b2025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b000e3-2516-932c-e063-6294a90a0e412025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b1a6c8-b4ff-089a-e063-6394a90a24692025-12-17Exact identifier
unii: 15FIX9V2JP
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shadesZINC OXIDE AND TITANIUM DIOXIDENoxell2cdbeb73-b805-f144-e063-6294a90a088d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
EtodolacETODOLACEdenbridge Pharmaceuticals LLC.bf1afcd5-e1da-4874-981f-f252cb0b32c22025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197686
rxcui: 199390
unii: 2M36281008
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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