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 4 of 17 · 331 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
unii: R9400W927I
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
iShanCare Balanitis CleansingISHANCARE BALANITIS CLEANSINGShenzhen Ishan Technology Co., Ltd3ca20a09-0a55-6f38-e063-6294a90a44be2026-02-12WarningsExact identifier
unii: R9400W927I
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
KetoconazoleKETOCONAZOLEANI Pharmaceuticals, Inc.00c1cac8-a865-4583-aaba-3a0f21fb31e62026-01-29Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCcad7c647-34a9-4e4e-83b3-8d78e58f588f2026-01-28Warnings, Adverse reactionsExact identifier
rxcui: 203088
unii: R9400W927I
KetoconazoleKETOCONAZOLENORTHSTAR RX LLCbf3e48fd-e063-42e6-acd1-580ddc6e93be2026-01-26Warnings, Adverse reactionsExact identifier
rxcui: 203088
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%ASCLEMED USA INC.6f1a5365-99df-4169-9382-14c2643e561d2026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA212443
rxcui: 203088
unii: R9400W927I
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KetoconazoleKETOCONAZOLE CREAM, 2%Sportpharm LLCd68f090d-82ea-413f-ab76-9254a88887362026-01-19Warnings, Adverse reactionsExact identifier
application number: ANDA212443
rxcui: 203088
unii: R9400W927I
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.482c0243-1073-f578-e063-6294a90adf5c2026-01-15WarningsExact identifier
unii: R9400W927I
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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