FDA.reportPublic FDA data

NDC 51672-4069-02 - 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
51672-4069
Requested NDC
51672-4069-02
Package NDCs from labels
51672-4069-1, 51672-4069-2, 51672-4069-02
Manufacturer
American Health Packaging
Effective date
2025-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin - American Health PackagingAmerican Health Packaging2025-09-17HUMAN PRESCRIPTION DRUG LABEL
PhenytoinSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2025-08-19HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2025-05-28HUMAN PRESCRIPTION DRUG LABEL
PhenytoinPAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma2024-11-19HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - REMEDYREPACK INC.REMEDYREPACK INC.2023-06-15HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - Major PharmaceuticalsMajor Pharmaceuticals2022-12-30HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Oral Suspension, USPATLANTIC BIOLOGICALS CORP.2021-01-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4069-1Phenytoin237 mL in 1 BOTTLESUSPENSION23717
51672-4069-2Phenytoin237 mL in 1 BOTTLESUSPENSION23717
51672-4069-2Phenytoin1 in 1 CARTONSUSPENSION117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4069PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]14Current NDC, Legacy NDC, 3 package rows20220429_093fd736-5971-47af-b4ef-08c1696cebe8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4069-1ML - Milliliter51672-4069ad64fdf1-fd54-465f-ac07-356560e8268f12012-07-24
51672-4069-2ML - Milliliter51672-4069bce3d4d5-d92a-43ce-83b8-eaf43c3eb96912025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
sucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
waterINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
SUCROSEINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]5

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 22 · 430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
unii: XF417D3PSL
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: C151H8M554
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: K679OBS311
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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