FDA.reportPublic FDA data

NDC 59762-0531-02 - 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
59762-0531
Requested NDC
59762-0531-02
Package NDCs from labels
59762-0531-2, 59762-0531-02
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-12-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0531-2Phenytoin1 in 1 CARTONSUSPENSION131
59762-0531-2Phenytoin237 mL in 1 BOTTLE, PLASTICSUSPENSION23731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0531PHENYTOIN SUSPENSION [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 2 package rows20250503_37943ec1-a8d2-42df-967e-6f96f84c017b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0531-1ML - Milliliter59762-05316bc19a70-2c0d-437c-9ca1-28dd3d03b6e612013-02-13
59762-0531-2ML - Milliliter59762-0531d79c9764-a7ae-4f3d-923b-76e8b8cf367812020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOINACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [GREENSTONE LLC]8
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [GREENSTONE LLC]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SUSPENSION [GREENSTONE LLC]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [GREENSTONE LLC]8
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [GREENSTONE LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [GREENSTONE LLC]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [GREENSTONE LLC]8
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [GREENSTONE LLC]8
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XPHENYTOIN SUSPENSION [GREENSTONE LLC]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [GREENSTONE LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [GREENSTONE LLC]8
VANILLININACTIVE INGREDIENTCHI530446XPHENYTOIN SUSPENSION [GREENSTONE LLC]8
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [GREENSTONE LLC]8

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 174 · 3,478 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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