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 73 of 175 · 3,486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tazza-X EXTREME 63% alcohol formula HAND SANITIZINGALCOHOLTazza Brands East Inc.3a073e9c-d6e6-e2d9-e063-6394a90a61532025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist StrawberryETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf545a-0f53-4fc0-e063-6294a90a89012025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist PeachETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf6f89-4a8d-86ad-e063-6294a90a97c32025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist WatermelonETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf871e-cb82-cf46-e063-6394a90a92962025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist CherryETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf95f1-a76e-c810-e063-6394a90a6e952025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA BREEZE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited82d9ae31-d6bc-4c74-8add-c4a2a4902c2a2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MINT CHOCOLATE CHIP ICE Cream SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedfa471391-2023-4b3a-b8f5-114dd93f9fe32025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SEASHELL SUNSHINE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited04952291-f74a-4a3b-8d7c-12f83593496d2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BEACH COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedccecaff5-8bd5-490e-8c73-a06991fa754e2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SHORTCAKE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited8c7fda8c-720f-413b-a4f5-cd8e9169ed6d2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST LYCHEE PEACHY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited9c62c74e-c69a-4fcf-8f4c-ec03a0bbf0272025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PAPAYA SUNSET SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitede998c88b-5a23-42e8-bdc1-6591ee62fb852025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINK GUAVA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited2a6f551b-2e2a-4788-b522-c1c7654491172025-12-24WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.56ac723b-3ede-4c94-bf4a-0572a7b42b592025-12-23WarningsExact identifier
unii: 3K9958V90M
MG FoamSan 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.11fc23dd-80e1-4df1-8c19-f759ecb34f1a2025-12-23WarningsExact identifier
unii: 3K9958V90M
TazzaETHANOLTazza Brands East Inc.391cc18f-ce63-5d88-e054-00144ff88e882025-12-23WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
unii: 3K9958V90M
Alcare Plus Foamed Antiseptic HandrubALCOHOLSC Johnson Professional USA, Inc.56900a58-b586-41e5-8b66-c9a006a79a9b2025-12-22WarningsExact identifier
unii: 3K9958V90M
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
unii: PDC6A3C0OX
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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