FDA.reportPublic FDA data

NDC 58177-912 - Prednisolone

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
58177-912
Package NDCs from labels
58177-912-03
Manufacturer
Physicians Total Care, Inc.
Effective date
2010-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prednisolone - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-01-05HUMAN PRESCRIPTION DRUG LABEL
Prednisolone - KV PharmaceuticalsKV Pharmaceuticals2006-12-26Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-912-03Prednisolone120 mL in 1 BOTTLESYRUP1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-912PREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]11 package rows20080313_d705cb30-d408-4e77-bc8b-619aa3563a15.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58177-912-03ML - Milliliter58177-912ebf3fac1-7860-4a8f-9c2d-1744fcc70a9412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONEACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
PrednisoloneACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
citric acidINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
D&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05PREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
flavosINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
glycyrrhizin (ammoniatedINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE (PREDNISOLONE) SYRUP [KV PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]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 96 of 174 · 3,476 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Kids Hand Sanitizer My Little PonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e45fe7d-b30c-9273-e063-6294a90ae8e12025-09-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Kids Hand Sanitizer Peppa pigALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e466475-351f-614e-e063-6394a90ab25a2025-09-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Kids Hand Sanitizer SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e46fe11-247f-36ad-e063-6294a90a1dd42025-09-08WarningsExact identifier
unii: 3K9958V90M
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
unii: 3K9958V90M
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
unii: 3K9958V90M
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Glycerin ChildrenGLYCERINRising Pharma Holdings, Inc.80a5a944-2882-4f8d-a955-ef827cead5f02025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact identifier
unii: 3K9958V90M
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Smart Care Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2869cb20-9cd4-54f5-e063-6294a90a5fea2025-09-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Vanilla Sugar 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.28694168-3362-de4f-e063-6394a90a2e352025-09-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Cucumber Melon Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e0a5382-7b58-fd6e-e063-6394a90abf662025-09-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e09c0aa-0241-0816-e063-6294a90a481e2025-09-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea Hand Sanitizer sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3080d8a2-a780-e79b-e063-6294a90ac6542025-09-05WarningsExact identifier
unii: 3K9958V90M
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3081e1b5-66b4-77a8-e063-6394a90a8dd32025-09-05WarningsExact identifier
unii: 3K9958V90M
Smart Care 1oz Hand Sanitizer Island Mango 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30847dd5-e378-1a35-e063-6294a90a43da2025-09-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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