FDA.reportPublic FDA data

NDC 50090-3539-01 - Phenytoin Sodium

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
50090-3539
Requested NDC
50090-3539-01
Package NDCs from labels
50090-3539-1, 50090-3539-0, 50090-3539-01
Manufacturer
A-S Medication Solutions
Effective date
2026-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin Sodium - A-S Medication SolutionsA-S Medication Solutions2026-07-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3539-02023-09-27These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-02023-09-27These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-12023-09-27These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-12023-09-27These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-02023-01-30These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-02023-01-30These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-12023-01-30These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-3539-12023-01-30These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3539-0Phenytoin Sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008
50090-3539-1Phenytoin Sodium90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3539PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20250516_ef4e97a7-cd18-47a9-a016-2eca5481a87e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3539-0EA - Each50090-353958ae0986-8663-4ac4-8f3d-2798a0b05ab612023-10-16
50090-3539-1EA - Each50090-35396abc4a2a-dd8e-4155-9a2b-0025799e926412023-10-16

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 3 of 108 · 2,142 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Extended Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.363cd347-d25e-42b9-9ce7-30642f3cb3532026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 855671
unii: 4182431BJH
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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