FDA.reportPublic FDA data

NDC 51672-4053-01 - 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
51672-4053
Requested NDC
51672-4053-01
Package NDCs from labels
51672-4053-6, 51672-4053-4, 51672-4053-1, 51672-4053-2, 51672-4053-3, 51672-4053-9, 51672-4053-01
Manufacturer
Golden State Medical Supply, Inc.
Effective date
2026-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mgGolden State Medical Supply, Inc.2026-08-06HUMAN PRESCRIPTION DRUG LABEL
Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mgTaSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Etodolac ER - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication SolutionsA-S Medication Solutions2017-11-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4053-1Etodolac100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
51672-4053-2Etodolac500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
51672-4053-3Etodolac1000 in 1 BOTTLETABLET, EXTENDED RELEASE10007
51672-4053-4Etodolac60 in 1 BOTTLETABLET, EXTENDED RELEASE607
51672-4053-6Etodolac30 in 1 BOTTLETABLET, EXTENDED RELEASE307
51672-4053-9Etodolac6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE67
51672-4053-9Etodolac10 in 1 CARTONTABLET, EXTENDED RELEASE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4053ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 7 package rows20241206_2c5b44b4-78d5-43b2-827d-d2763b6672b3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4053-1EA - Each51672-4053acd1688a-5c0d-40e2-8609-8bb0ad3aa07712012-07-24
51672-4053-4EA - Each51672-405353692fdb-b030-4afc-9138-041d7c2e0a9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
EtodolacACTIVE MOIETY2M36281008ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Indigotindisulfonate SodiumINACTIVE INGREDIENTD3741U8K7LETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
PolydextroseINACTIVE INGREDIENTVH2XOU12IEETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Polyethylene Glycol 8000INACTIVE INGREDIENTQ662QK8M3BETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
PovidonesINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2
TriacetinINACTIVE INGREDIENTXHX3C3X673ETODOLAC TABLET, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]2

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 76 of 112 · 2,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RV Illuminance Serum Tint Broad Spectrum 15 Tan SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b5cca-4e4f-efb6-e063-6294a90a62062024-12-24WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Warm CaramelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b9147-3c7a-d549-e063-6394a90a68692024-12-24WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incaefd7884-6bc3-4b0b-ba36-1f3e8fe49f932024-12-23WarningsExact identifier
unii: 15FIX9V2JP
Kids SPF50Plus Mineral Sunscreen Rollerball Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd3bdda65-bcb4-42d9-84af-d14c7f4421bd2024-12-23WarningsExact identifier
unii: 15FIX9V2JP
Kids SPF50 Plus Mineral Sunscreen Continuous Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd5ffe993-de8f-4623-a010-9cb8dd70de072024-12-23WarningsExact identifier
unii: 15FIX9V2JP
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc8b298516-70df-47ab-834f-51dcde28a43a2024-12-23WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE6a14ee23-28c9-4704-8af9-d1c4db0d92562024-12-23WarningsExact identifier
unii: 15FIX9V2JP
EcoStick Sunscreen SPF 35ZINC OXIDE, TITANIUM DIOXIDEStream2Sea, LLCeba17b7a-5e96-4462-9b71-44c2bc577dce2024-12-21WarningsExact identifier
unii: 15FIX9V2JP
Planet Protecting Sunscreen 30TITANIUM DIOXIDEStream2Sea, LLC89e44c5f-121e-4fdd-b9e0-023909ea32f52024-12-21WarningsExact identifier
unii: 15FIX9V2JP
Face Reality mineral matte spf 28 Sunscreen SPF 28ZINC OXIDE, TITANIUM DIOXIDEFace Reality, LLC29b70afe-cf9d-d0ba-e063-6394a90a1cc42024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
unii: 15FIX9V2JP
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAINOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ac9a5-f609-d804-e063-6394a90abd052024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299ad424-16a8-66b1-e063-6394a90a07532024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afef9-758f-74e1-e063-6294a90a80722024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3276-7973-d33f-e063-6294a90a6ce12024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TANOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299afe24-d496-5745-e063-6394a90aa1b32024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b1f9a-34fd-cb50-e063-6394a90af9252024-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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