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 4 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICAEnergique, Inc.89c86e7b-304c-43a6-81e7-373d95c9fac12025-10-06WarningsExact identifier
unii: LMI26O6933
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: LMI26O6933
PhenytoinPHENYTOINAmerican Health Packagingf9fe4c92-2761-4cb4-9cf3-7066e240e0142025-09-17Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
PhenytoinPHENYTOINSun Pharmaceutical Industries, Inc.093fd736-5971-47af-b4ef-08c1696cebe82025-08-19Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: LMI26O6933
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
PhenytoinPHENYTOINATLANTIC BIOLOGICALS CORP.09daf485-3355-44cb-92af-072dd281e1292025-05-28Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
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
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
unii: B1QE5P712K
Bestmade Natural Products AluminaALUMINABestmade Natural Products2f824dae-5cd2-5ac7-e063-6394a90aa9852025-03-04WarningsExact identifier
unii: LMI26O6933
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: LMI26O6933
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.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: LMI26O6933
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
Bestmade Natural Products BM40ALUMINAD7, CAUSTICUMD8, GELSEMIUMD3, MOSCHUSD14, PLUMBUMD9, SECALE CORND4, ZINCUM ACETD9Bestmade Natural Productsef43f183-1be9-4c7e-e053-2a95a90a4b062025-01-23WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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