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 81 of 175 · 3,486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EO HAND SANITIZER UnscentedALCOHOLEO Products, LLC7c2bf597-65f1-44ad-9cfd-05cd7e9973c82025-11-20WarningsExact identifier
unii: 3K9958V90M
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Lavender Hand Sanitizing WipesETHANOLWhole Foods Market, Inc.039edd3c-8ccd-0c6c-e063-6294a90ab9ba2025-11-20WarningsExact identifier
unii: 3K9958V90M
Lavender Hand Sanitizer WipesETHANOLWhole Foods Market, Inc.039dfc12-6088-1b1f-e063-6394a90a7e922025-11-20WarningsExact identifier
unii: 3K9958V90M
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
unii: 3K9958V90M
Plus Brasept Alcocol GelALCOHOLNEWDROP NORTH AMERICA LLCf791c99c-5879-9ba2-e053-6394a90ad3c72025-11-20WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
unii: 3K9958V90M
INSTANT HAND SANITIZER ClassicETHYL ALCOHOLUniversal Distribution Center LLC65faf3d6-4e1c-4092-ac77-f6d77bf49cd62025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer coconut lemonETHYL ALCOHOLEO Products, LLCe42fae4c-4e6e-4309-b6fa-2fbb95c5cbc22025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes lavender aloeETHYL ALCOHOLEO Products, LLC8128b366-c2e3-4ffc-948f-299227a364a12025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes coconut lemonETHYL ALCOHOLEO Products, LLC809049d8-a71e-44e1-986e-0473ee0fb6702025-11-19WarningsExact identifier
unii: 3K9958V90M
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
unii: 3K9958V90M
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact identifier
unii: 3K9958V90M
Sani-SpritzALCOHOLABC Compounding Co., Inc.ac88c676-c396-4fb8-9e5c-77c726ed69d82025-11-19WarningsExact identifier
unii: 3K9958V90M
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
unii: 3K9958V90M
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
PrednisolonePREDNISOLONE ORALChartwell Governmental & Specialty RX, LLC.2dac9898-6492-4f34-ad86-83a902e0fe0b2025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 283077
unii: 9PHQ9Y1OLM
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLABC Compounding Co., Inc.ee46cb57-c79c-4edf-bc88-4a4f8a95bfc82025-11-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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