FDA.reportPublic FDA data

NDC 51672-4146-01 - Phenytoin

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
51672-4146
Requested NDC
51672-4146-01
Package NDCs from labels
51672-4146-6, 51672-4146-1, 51672-4146-3, 51672-4146-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin - REMEDYREPACK INC.REMEDYREPACK INC.2026-05-19HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - Major PharmaceuticalsMajor Pharmaceuticals2026-04-29HUMAN PRESCRIPTION DRUG LABEL
PhenytoinSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-03-27HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2026-02-25HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - American Health PackagingAmerican Health Packaging2024-10-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4146-1Phenytoin100 in 1 BOTTLETABLET, CHEWABLE10013
51672-4146-3Phenytoin1000 in 1 BOTTLETABLET, CHEWABLE100013
51672-4146-6Phenytoin30 in 1 BOTTLETABLET, CHEWABLE3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4146PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]11Current NDC, Legacy NDC, 3 package rows20220702_78b38e7b-1460-4adc-b738-320ffa6259c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4146-1EA - Each51672-4146cc471fd7-aa57-418d-af8a-92f796dded6c12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
HypromellosesINACTIVE INGREDIENT3NXW29V3WOPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
Magnesium StearateINACTIVE INGREDIENT70097M6I30PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
Saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
SucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
TalcINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
Saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
SucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
TalcINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1

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 7 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lung Large Intestine Meridian OpenerALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHURDeseret Biologicals, Inca5c17770-e1c0-48e7-8947-c0434c22cdab2024-02-21WarningsExact identifier
unii: LMI26O6933
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: 3NXW29V3WO
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: LMI26O6933
Mineffect acid indigestion and heartburn reliefALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUMKadesh Incoporation Co,Ltd048367ff-a9bb-46a3-a835-aa3ab391eee42023-10-31WarningsExact identifier
unii: LMI26O6933
Mineffect facial skin protectant and acne treatment solutionALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, MAGNESIA SULPHURICA, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltdf6b3ea92-2382-4c3f-8ed9-31ea26fd47ee2023-10-31WarningsExact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron84266aa8-b80c-a2a5-e053-2991aa0a68e02023-10-18Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron8426b2bb-4401-9015-e053-2991aa0a09932023-10-18Exact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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