FDA.reportPublic FDA data

NDC 70518-4236-00 - Ketoconazole

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
70518-4236
Requested NDC
70518-4236-00
Package NDCs from labels
70518-4236-0, 70518-4236-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KETOCONAZOLE CREAM Rx onlyREMEDYREPACK INC.2026-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4236-0Ketoconazole30 g in 1 TUBECREAM303
70518-4236-0Ketoconazole1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4236KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [REMEDYREPACK INC.]1Current NDC, 2 package rows20241213_ea56cddf-94c9-46b6-8791-995b741cfbd7.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 9 of 17 · 331 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLESun Pharmaceutical Industries, Inc.39b85d6a-9133-42e6-b7f8-58f045e9b9f02025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 203088
unii: R9400W927I
KetoconazoleKETOCONAZOLEAmici Pharma Inc.369f31da-d3c3-49b8-956f-f705987601642025-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.39d31bed-9caa-41bb-afdb-25fc18609c142025-04-24Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEA-S Medication Solutionsa884bad7-df8c-45de-8c4f-42034b40e4252025-04-23Adverse reactionsExact identifier
unii: R9400W927I
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
unii: R9400W927I
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEZydus Lifesciences Limitedc004ee91-558a-450b-9e4e-d11ab9d280542025-03-12Exact identifier
unii: R9400W927I
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
KetoconazoleKETOCONAZOLECosette Pharmaceuticals, Inc.2d7c8dd1-59b5-2645-e063-6394a90a5bda2025-02-06Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%NuCare Pharmaceuticals,Inc.05f9938a-1577-adec-e063-6294a90af3492025-01-31Warnings, Adverse reactionsExact identifier
application number: ANDA212443
rxcui: 203088
unii: R9400W927I
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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