FDA.reportPublic FDA data

NDC 67046-585-03 - 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
67046-585
Requested NDC
67046-585-03
Package NDCs from labels
67046-585-30, 67046-585-60, 67046-585-03
Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-04-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin Sodium - Contract Pharmacy Services-PAContract Pharmacy Services-PA2010-04-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-585-302019-10-21C16284748780-1956f9ecf-bfa3-621f-e053-dbdaa90a74adExtended Phenytoin Sodium Capsules USP, 100 mg
67046-585-602019-10-21C16284748780-1956f9ecf-bfa3-621f-e053-dbdaa90a74adExtended Phenytoin Sodium Capsules USP, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-585-30Phenytoin Sodium30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE301
67046-585-60Phenytoin Sodium60 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-585PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20100407_da966d98-94a6-463e-aff7-771406c4c836.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenytoin SodiumACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
gelatinINACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
sodium propionateINACTIVE INGREDIENTDK6Y9P42INPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
talcINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]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 105 · 2,099 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Phenytoin SodiumPHENYTOIN SODIUMMajor Pharmaceuticals46d5c0d1-a97b-46d9-8cf4-9947806733372026-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA040684
rxcui: 855671
unii: 4182431BJH
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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