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 73 of 112 · 2,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d309eebc-44f4-bce6-e053-2995a90a3bd22025-01-01WarningsExact identifier
unii: 15FIX9V2JP
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a3bcb-5113-0a85-e053-2995a90a39372025-01-01WarningsExact identifier
unii: 15FIX9V2JP
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.d30a9f96-f99b-4610-e053-2995a90a3f912025-01-01WarningsExact identifier
unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a7ecc-ea54-d1b9-e053-2995a90a70172025-01-01WarningsExact identifier
unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a87b9-90f9-35b2-e053-2995a90aea2c2025-01-01WarningsExact identifier
unii: 15FIX9V2JP
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.d30ab7a5-d38c-ba62-e053-2995a90a57fd2025-01-01WarningsExact identifier
unii: 15FIX9V2JP
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.f8361aa8-c3ad-0c47-e053-6394a90a6ab02025-01-01WarningsExact identifier
unii: 15FIX9V2JP
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.a4364c8d-8b74-130e-e053-2995a90ad1c12025-01-01WarningsExact identifier
unii: 15FIX9V2JP
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMDTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLCff95a7b7-3cb4-41b0-866d-69361354a0bc2025-01-01WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup GoldenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94c0a2-8a4c-39b9-e063-6394a90acf8c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup LightHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a948e37-0554-d953-e063-6394a90a75e62024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup FairHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a947e1d-286f-a939-e063-6394a90a07192024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup TanHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94a668-24cb-e0f2-e063-6294a90a79d32024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup MediumHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94c0a2-8a47-39b9-e063-6394a90acf8c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20TITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a962944-9155-9b70-e063-6294a90ac5352024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 MediumTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a96811c-3ea6-15bc-e063-6394a90ac3bd2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Normal to Dry SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp414538d6-9108-54bf-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Preo and Protect PrimerTITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMERRevlon Consumer Products Corp8eebf23e-7fce-dfc0-e053-2995a90ae3222024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon PhotoReady BB Cream Skin PerfectorOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410ca372-4698-029d-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Oily to Combination SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410d1cb2-6c92-1ca3-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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