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 66 of 111 · 2,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
unii: 15FIX9V2JP
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
unii: 15FIX9V2JP
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
unii: 15FIX9V2JP
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
unii: 15FIX9V2JP
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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