FDA.reportPublic FDA data

NDC 61040-129-01 - SOFSKIN HYDROCORTISONE 1 PERCENT

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
61040-129
Requested NDC
61040-129-01
Package NDCs from labels
61040-129-01, 61040-129-11
Manufacturer
GOPALDAS VISRAM AND COMPANY LIMITED
Effective date
2024-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SOFSKIN HYDROCORTISONE 1 PERCENT - GOPALDAS VISRAM AND COMPANY LIMITEDGOPALDAS VISRAM AND COMPANY LIMITED2024-12-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61040-129-01SOFSKIN HYDROCORTISONE 1 PERCENT28.4 g in 1 TUBECREAM28.41
61040-129-11SOFSKIN HYDROCORTISONE 1 PERCENT1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61040-129SOFSKIN HYDROCORTISONE 1 PERCENT (HYDROCORTISONE HCL) CREAM [GOPALDAS VISRAM AND COMPANY LIMITED]12 package rows20241212_28ed3770-890f-e480-e063-6294a90af4f8.zip

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 34 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEAmneal Pharmaceuticals of New York LLC9fe627ad-4aba-4bd1-8590-6cc2d61674ba2024-07-03Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
unii: B6E5W8RQJ4
HydrocortisoneHYDROCORTISONENuCare Pharmaceuticals,Inc.720357e2-6f01-737d-e053-2a95a90ae54b2024-06-10Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICRising Pharma Holdings, Inc.35768adc-b578-4c2e-b461-22de3135a7892024-06-10Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONENuCare Pharmaceuticals,Inc.5f9c25b1-67d0-11ae-e053-2a91aa0ad8f42024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.1c834ba0-86b6-8e61-e063-6394a90a192d2024-06-04WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MyMedic HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.197fc623-2fb9-184c-e063-6394a90a41042024-05-28WarningsExact identifier
unii: WI4X0X7BPJ
TheraCare Hydrocortisone CreamHYDROCORTISONEVeridian Healthcare01cb7b47-2c3c-707d-e063-6294a90a5d972024-05-21WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Anti ItchHYDROCORTISONENeilmed Pharmaceuticals Inc.14b4f066-fde4-ac97-e063-6394a90ae64c2024-04-20WarningsExact identifier
unii: WI4X0X7BPJ
Walgreens Scalp Relief External analgesicHYDROCORTISONEWalgreen Companyda0a24c7-9295-4f22-b2c7-40000dad4b812024-04-18WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hydrocortisoneHYDROCORTISONEBryant Ranch Prepacka2c18606-631f-4e89-8936-3d635a41c37d2024-04-03Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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