FDA.reportPublic FDA data

NDC 60505-0041-01 - 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
60505-0041
Requested NDC
60505-0041-01
Package NDCs from labels
60505-0041-1, 60505-0041-2, 60505-0041-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-16
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.2026-09-16HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyApotex Corp. | Apotex Inc.2026-09-11HUMAN PRESCRIPTION DRUG LABEL
Etodolac - St. Mary’s Medical Park PharmacySt. Mary’s Medical Park Pharmacy2026-06-25HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2026-05-22HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2026-04-29HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2025-12-16HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Bryant Ranch PrepackBryant Ranch Prepack2025-11-14HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyPreferred Pharmaceuticals Inc.2025-03-24HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyRPK Pharmaceuticals, Inc.2024-12-19HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Quality Care Products LLCQuality Care Products LLC2024-12-17HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Bryant Ranch PrepackBryant Ranch Prepack2024-09-05HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2024-03-20HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication SolutionsA-S Medication Solutions2023-12-10HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Proficient Rx LPProficient Rx LP2023-08-01HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC - DIRECT RXDIRECT RX2023-04-17HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN PRESCRIPTION DRUG LABEL
NuDroxiPAK E-400 - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-05-07HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyPreferred Pharmaceuticals Inc.2020-05-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0041-1Etodolac100 in 1 BOTTLETABLET, FILM COATED10016
60505-0041-2Etodolac500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0041ETODOLAC 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
60505-0041-1EA - Each60505-0041afbac5a4-38be-4949-a771-cbf64f0dcfb012012-07-24

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 [PD-RX PHARMACEUTICALS, INC.]4
etodolacACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]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 4 of 241 · 4,802 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SC HERBALMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCf34ad1c1-9b4d-4efa-b824-7b7ff53509742026-08-20WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
unii: L7T10EIP3A
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
unii: L7T10EIP3A
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
unii: L7T10EIP3A
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
unii: L7T10EIP3A
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
unii: L7T10EIP3A
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
SC HERBALMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLCb79b6f57-d062-4c6d-ade8-dfa841c6bf0f2026-08-20WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
EtodolacETODOLACBryant Ranch Prepack03458123-e27c-4447-9ef3-3bd32481cb972026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197686
unii: 2M36281008
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC5965eb2a-1261-5258-e063-6294a90a7c2d2026-08-19WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
unii: L7T10EIP3A
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
unii: L7T10EIP3A
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
unii: L7T10EIP3A
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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