FDA.reportPublic FDA data

NDC 51672-4146-03 - 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
51672-4146-03
Package NDCs from labels
51672-4146-6, 51672-4146-1, 51672-4146-3, 51672-4146-03
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 1 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: LMI26O6933
unii: C151H8M554
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: LMI26O6933
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: LMI26O6933
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: LMI26O6933
Metal-ChordALLIUM CEPA, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ALUMINA, ARSENICUM METALLICUM, BERBERIS VULGARIS, CADMIUM METALLICUM, CARDUUS MARIANUS, CETRARIA ISLANDICA, CUPRUM METALLICUM, CYSTEINUM, GLYCYRRHIZA GLABRA, HEPAR SUIS, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NUX VOMICA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PYRIDOXINUM HYDROCHLORICUM, SELENIUM METALLICUM, STILLINGIA SYLVATICA, THYROIDINUM, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALEEnergetix Corporationea4d26a8-acf2-46ed-9a69-df7764cc4cfd2026-08-11WarningsExact identifier
unii: LMI26O6933
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
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
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
GUNA-BOWELALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -Guna spa75465821-a889-4697-b470-e9588a5232052026-06-10WarningsExact identifier
unii: LMI26O6933
Borago NicotianaBORAGO NICOTIANAUriel Pharmacy Inc.306f9eee-877b-46ee-9a36-894fa321b3d32026-06-05WarningsExact identifier
unii: LMI26O6933
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Phenytoin InfatabsPHENYTOINPrasco Laboratories3580e6a8-f7c3-44a0-a1eb-2a84ae589d212026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 1313885
unii: 6158TKW0C5
PhenytoinPHENYTOINREMEDYREPACK INC.31e8a777-75b1-4f48-9682-0bcc3189ad262026-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA200565
ndc (package): 70518-0841-2
ndc (package): 70518-0841-3
ndc (package): 70518-0841-1
ndc (package): 70518-0841-0
ndc (product): 70518-0841
rxcui: 1313885
spl id: 522f9466-a36b-e74a-e063-6394a90af379
spl set id: 31e8a777-75b1-4f48-9682-0bcc3189ad26
unii: 6158TKW0C5
Dilantin InfatabsPHENYTOINParke-Davis Div of Pfizer Incca119a89-2394-4d34-8078-cd1fa4e8e2f12026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 1313885
unii: 6158TKW0C5

Reported adverse events (FAERS/openFDA)#

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