FDA.reportPublic FDA data

NDC 0121-4675-05 - VALPROIC ACID

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
0121-4675
Requested NDC
0121-4675-05
Package NDCs from labels
0121-4675-05, 0121-4675-40, 0121-4675-00
Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-01-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VALPROIC ACIDPAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma2025-01-24HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4675-00VALPROIC ACID10 in 1 TRAYSOLUTION1021
0121-4675-00VALPROIC ACID10 in 1 CASESOLUTION1021
0121-4675-05VALPROIC ACID5 mL in 1 CUP, UNIT-DOSESOLUTION521
0121-4675-40VALPROIC ACID10 in 1 TRAYSOLUTION1021
0121-4675-40VALPROIC ACID4 in 1 CASESOLUTION421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4675VALPROIC ACID SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]21Current NDC, Legacy NDC, 5 package rows20250205_7d5cb52e-37dd-4dfa-a6f4-09f9548846c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4675-00ML - Milliliter0121-4675d4cb1f92-9fc7-49c7-8305-259e6a62ff5612017-08-11
0121-4675-05ML - Milliliter0121-46757721a5c8-b81d-4ac4-af21-ba882ec53c9212013-02-13
0121-4675-10ML - Milliliter0121-4675c25e6ad4-cc43-4061-9178-0e9d389b666312013-02-13
0121-4675-40ML - Milliliter0121-46756da9fdac-26ec-4a1e-925c-4de7c110ac2412017-08-11
0121-4675-55ML - Milliliter0121-4675e1bac19f-eb9b-429b-a1ef-ef2ab25f0bd912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RVALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6

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 9 of 32 · 636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
unii: PDC6A3C0OX
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
unii: PDC6A3C0OX
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Gaezoa CreamPOTERIUM OFFICINALE ROOT EXTRACT, CAMELLIA SINENSIS LEAF, ELAEAGNUS GLABRA EXTRACTBIOHERB Co., Ltd.4731b85c-bbd5-fd26-e063-6394a90a6a732025-12-30WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: PDC6A3C0OX
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLCf710d107-0403-21c5-e053-6394a90a03722025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Foster and Thrive Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLStrategic Sourcing Services LLC0042e9a0-9693-d7e0-e063-6294a90ae6c62025-12-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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