FDA.reportPublic FDA data

NDC 66689-036-01 - 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
66689-036
Requested NDC
66689-036-01
Package NDCs from labels
66689-036-01, 66689-036-50
Manufacturer
VistaPharm, LLC
Effective date
2024-05-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin - VistaPharm, LLCVistaPharm, LLC2024-05-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-036-502024-01-30C16284748780-11030e364-fcc6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PHENYTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for PHENYTOIN ORAL SUSPENSION. PHENYTOIN oral suspension Initial U.S. Approval: 1953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-036PHENYTOIN SUSPENSION [VISTAPHARM, LLC]19Legacy NDC20240510_85cc5cd9-695f-4a71-9275-e0099c505185.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-036-01ML - Milliliter66689-03655e6e511-b376-4b6d-9876-c161285ad4c212012-07-24
66689-036-50ML - Milliliter66689-036099bc12b-07cc-470d-8e68-2718eb515a9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
SucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [VISTAPHARM INC.]3

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 35 · 695 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Phenytoin InfatabsPHENYTOINPrasco Laboratories3580e6a8-f7c3-44a0-a1eb-2a84ae589d212026-05-22Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
PhenytoinPHENYTOINREMEDYREPACK INC.31e8a777-75b1-4f48-9682-0bcc3189ad262026-05-19Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Dilantin InfatabsPHENYTOINParke-Davis Div of Pfizer Incca119a89-2394-4d34-8078-cd1fa4e8e2f12026-05-12Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
PhenytoinPHENYTOINMajor Pharmaceuticals08a9d26b-4419-43ec-98f3-43d4534c2e762026-04-29Warnings, Adverse reactionsExact identifier
unii: 6158TKW0C5
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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