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 66 of 112 · 2,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: LMI26O6933
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
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.