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 75 of 175 · 3,486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: 8SKN0B0MIM
unii: 506T60A25R
B-Pure Moisturizing Hand Sanitizer Sugar Pistachio ScentedALCOHOLFourstar Group USA, Inc.b80c402e-ecef-42fe-8cf5-7aa26254a3fe2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ab5e8-029a-fe9d-e063-6294a90ac14d2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ad5ba-253f-2a30-e063-6294a90a261d2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462af072-6709-546f-e063-6294a90aacc82025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b1d38-c7fa-992f-e063-6294a90ab78f2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b2d3f-67b0-c393-e063-6294a90a208a2025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b36d0-0a1f-bda8-e063-6294a90a57922025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b39e9-cf8e-3268-e063-6394a90a69c02025-12-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462a1437-154c-0324-e063-6294a90a12662025-12-17WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLSolupharm Pharmazeutische Erzeugnisse GmbH372d3eb5-78ee-414c-a146-4a19e22661842025-12-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEEdenbridge Pharmaceuticals LLC.1793e218-7b49-497d-879f-1020de6e6d682025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 283077
Kay Hand Sanitizer FoamETHYL ALCOHOLEcolab Inc.f82eaaaf-cead-497a-8b95-9668310511872025-12-17WarningsExact identifier
unii: 3K9958V90M
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
Keystone Liquid Hand SanitizerALCOHOLEcolab Inc.1d808912-f1ad-4eed-a52d-6c6a363ddba22025-12-16WarningsExact identifier
unii: 3K9958V90M
EcolabALCOHOLEcolab Inc.69962e54-2e1f-404a-b039-5ebf77cabd5f2025-12-16WarningsExact identifier
unii: 3K9958V90M
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
unii: 3K9958V90M
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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