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 70 of 112 · 2,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: LMI26O6933
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: 15FIX9V2JP
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
unii: 15FIX9V2JP
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
unii: 15FIX9V2JP
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
unii: 15FIX9V2JP
D-37ALUMINUM OXIDE, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, AND SULFURDNA Labs, Inc.3b408532-b84b-4398-ab8d-64d5a9c8d0922025-01-13WarningsExact identifier
unii: LMI26O6933
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: LMI26O6933
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: LMI26O6933
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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