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 15 of 176 · 3,516 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Little Leaves Hand Sanitizer Watermelon and CoconutETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d21713-f279-489c-e063-6394a90a67792026-07-08WarningsExact identifier
unii: 3K9958V90M
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd561af7a3-25a5-1384-e063-6394a90abb592026-07-08WarningsExact identifier
unii: 3K9958V90M
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
PrednisolonePREDNISOLONE ORALTulex Pharmaceuticals Inc757b41c4-a0fe-4a09-8816-a4cdb7558f412026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 283077
unii: 9PHQ9Y1OLM
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
unii: 3K9958V90M
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
ATTITUDE Super Leaves Hand Sanitizer Lemon LeavesETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d3c8c0-74d5-f49d-e063-6394a90a48152026-07-07WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb487f98e-63b1-40d9-bc8b-524b4be3f86c2026-07-06WarningsExact identifier
unii: 3K9958V90M
Beach In A Bottle Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC556fa4b6-c1af-bc36-e063-6394a90a7f312026-07-06WarningsExact identifier
unii: 3K9958V90M
Sugarcoat Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC5570284d-0872-1fee-e063-6294a90a9b652026-07-06WarningsExact identifier
unii: 3K9958V90M
Whipped Creme Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC5570977b-6085-98d9-e063-6394a90aa1742026-07-06WarningsExact identifier
unii: 3K9958V90M
Santal Suede Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC55712a8b-e633-2427-e063-6294a90a7c5a2026-07-06WarningsExact identifier
unii: 3K9958V90M
Sea Salt Bergamot Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC55737186-41b1-b563-e063-6294a90ab8e92026-07-06WarningsExact identifier
unii: 3K9958V90M
Bourbon Vanilla Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC55744cc5-5ef6-f2a1-e063-6394a90a3e6d2026-07-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizing WipesETHYL ALCOHOLUpLift Brands LLC044361fe-1e16-4fea-9094-a2d88c890d9c2026-07-06Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLEverywhereAire LLCb48f9e6b-c616-3607-e053-2995a90a37f52026-07-06WarningsExact identifier
unii: 3K9958V90M
PlaneAire Hands hand sanitizerETHYL ALCOHOLEverywhereAire LLCb6af3009-78c2-2312-e053-2995a90af90a2026-07-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer gelALCOHOLEverywhereAire LLCd2a6c866-3f1e-20f1-e053-2995a90a26cc2026-07-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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