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 2 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenytoinPHENYTOINMajor Pharmaceuticals08a9d26b-4419-43ec-98f3-43d4534c2e762026-04-29Warnings, Adverse reactionsExact identifier
application number: ANDA200565
ndc (package): 0904-7199-07
ndc (product): 0904-7199
rxcui: 1313885
spl id: 066e29d5-dcad-4017-a345-085432105a41
spl set id: 08a9d26b-4419-43ec-98f3-43d4534c2e76
unii: 6158TKW0C5
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
PhenytoinPHENYTOINSun Pharmaceutical Industries, Inc.78b38e7b-1460-4adc-b738-320ffa6259c22026-03-27Warnings, Adverse reactionsExact identifier
application number: ANDA200565
ndc (package): 51672-4146-6
ndc (package): 51672-4146-1
ndc (package): 51672-4146-3
ndc (product): 51672-4146
ndc11 (package): 51672414601
rxcui: 1313885
spl id: 4e03fb7d-d33a-2472-e063-6394a90a9b81
spl set id: 78b38e7b-1460-4adc-b738-320ffa6259c2
unii: 6158TKW0C5
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: LMI26O6933
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: LMI26O6933
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: LMI26O6933
PhenytoinPHENYTOINNCS HealthCare of KY, LLC dba Vangard Labs98bd1d9f-b1a4-49eb-a0b4-a790265710dd2026-02-25Warnings, Adverse reactionsExact identifier
application number: ANDA200565
ndc (package): 0615-8623-39
ndc (product): 0615-8623
rxcui: 1313885
spl id: efe57937-39ce-420b-a611-68d08a7b246d
spl set id: 98bd1d9f-b1a4-49eb-a0b4-a790265710dd
unii: 6158TKW0C5
MERC CORRALUMINA, BRYONIA, COLOCYNTHIS, CHINA OFF, LYCOPODIUM, THUJA OCC, NUX VOMBM Private Limited3b29d70d-f291-dad2-e063-6294a90a07f52026-02-12WarningsExact identifier
unii: LMI26O6933
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: LMI26O6933
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: LMI26O6933
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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