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
REMEDYREPACK INC.
Effective date
2026-10-20
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 onlyREMEDYREPACK INC.2026-10-20HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyApotex Corp. | Apotex Inc.2026-09-11HUMAN 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 67 of 111 · 2,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
unii: 1K09F3G675
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
unii: 15FIX9V2JP
KARYNG Complete SPF Sunscreen Light/MediumSUNSCREENKaryng LLC33596253-413d-fba3-e063-6394a90a39e42025-04-22WarningsExact identifier
unii: 15FIX9V2JP
KARYNG Complete SPF Sunscreen Medium/DarkSUNSCREENKaryng LLC335eee1e-ef1c-41da-e063-6294a90ac2732025-04-22WarningsExact identifier
unii: 15FIX9V2JP
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
unii: 15FIX9V2JP
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
unii: 15FIX9V2JP
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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