FDA.reportPublic FDA data

NDC 0641-2555-41 - PHENYTOIN SODIUM

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
0641-2555
Requested NDC
0641-2555-41
Package NDCs from labels
0641-2555-41, 0641-2555-10, 0641-2555-45
Manufacturer
Henry Schein, Inc.
Effective date
2024-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENYTOIN SODIUM - Henry Schein, Inc.Henry Schein, Inc.2024-12-26HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - Henry Schein, Inc.Henry Schein, Inc.2024-08-19HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - General Injectables & Vaccines, Inc.General Injectables & Vaccines, Inc.2022-12-29HUMAN PRESCRIPTION DRUG LABEL
PHENYTOIN SODIUM - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-2555-10Phenytoin Sodium10 in 1 CARTONINJECTION1027
0641-2555-41Phenytoin Sodium5 mL in 1 VIALINJECTION527
0641-2555-45Phenytoin Sodium25 in 1 CARTONINJECTION2527

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-2555PHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]27Current NDC, Legacy NDC, 3 package rows20240410_035a8d4e-2063-4240-83cb-d7eebcabe301.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-2555-10ML - Milliliter0641-25552c387154-2213-431b-ac08-43e66ab3415c12024-01-04
0641-2555-41ML - Milliliter0641-25554e2b7ec4-9ce3-48e0-b8b8-faf7914379ec12012-07-24
0641-2555-45ML - Milliliter0641-2555698657cf-7999-407b-a4d4-854a0169220312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
Phenytoin SodiumACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM (PHENYTOIN SODIUM ) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM (PHENYTOIN SODIUM ) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, 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 1 of 155 · 3,100 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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