FDA.reportPublic FDA data

NDC 76348-997-01 - NAIL RENU Antifungal

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
76348-997
Requested NDC
76348-997-01
Package NDCs from labels
76348-997-01, 76348-997-02
Manufacturer
RENU LABORATORIES, INC.
Effective date
2023-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NAIL RENU ANTIFUNGAL CREAMRENU LABORATORIES, INC.2023-07-24HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-997-022025-01-30C16284748780-12cef2736-7ba2-d83d-e063-dadaa90ab31fNAIL RENU ANTIFUNGAL CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-997-01NAIL RENU Antifungal28 g in 1 TUBECREAM281
76348-997-02NAIL RENU Antifungal1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-997NAIL RENU ANTIFUNGAL (MICONAZOLE NITRATE 2%) CREAM [RENU LABORATORIES, INC.]12 package rows20230816_003d6dd9-f805-3185-e063-6394a90afc94.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 24 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
unii: VW4H1CYW1K
ClinolipidOLIVE OIL AND SOYBEAN OILBaxter Healthcare Corporationae98eb03-c0e7-49d1-b024-77968e3d9d6e2025-07-24Warnings, Adverse reactionsExact identifier
unii: 6UYK2W1W1E
Rheumatic-Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.9cae6bd9-5427-4482-e053-2a95a90a7a762025-07-23WarningsExact identifier
unii: 8SKN0B0MIM
DetoxifierCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS,CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, NUX VOMICA, URICUM ACIDUM.Newton Laboratories, Inc.9d720ba6-294f-4c9b-e053-2a95a90ac2d92025-07-23WarningsExact identifier
unii: 8SKN0B0MIM
DetoxifierCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS,CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, NUX VOMICA, URICUM ACIDUM.Newton Laboratories, Inc.9d72d9ec-c7c3-7b45-e053-2a95a90afe962025-07-22WarningsExact identifier
unii: 8SKN0B0MIM
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
unii: VW4H1CYW1K
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
unii: VW4H1CYW1K
Miconazole 3MICONAZOLE NITRATETARGET Corporation12a2e441-4fdf-4c5e-b033-ba05ef12fc2f2025-07-18WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateMICONAZOLE NITRATESTRATEGIC SOURCING SERVICES LLC966a1000-3b08-4f2c-a9f8-568f2524b7172025-07-15WarningsExact identifier
unii: VW4H1CYW1K
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ConazolMICONAZOLE NITRATELaboratorios Liomont, S.A. de C.V.84780538-8618-5750-e053-2a91aa0a60542025-07-07WarningsExact identifier
unii: VW4H1CYW1K
Lagicam antifungalMICONAZOLE NITRATEGenomma Lab USA, Inc.85043273-7411-48f5-8ad4-3f00e03cafa32025-07-02WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.eaca3e39-6ea0-4d7e-803c-db22024ad9f92025-07-01WarningsExact identifier
unii: VW4H1CYW1K
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateANTIFUNGAL LIQUID CONTINUOUS SPRAYChain Drug Consortium, LLC7f6912a6-a576-4138-bd78-a075a7d240362025-06-27WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREERite Aid Corporation5e2f2372-4b79-4b6a-bdea-74289b1e20532025-06-21WarningsExact identifier
unii: VW4H1CYW1K
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sunshine YeastReliefVAGINAL YEAST RELIEFApcco Labs, Inc37de3347-7ad2-b9e7-e063-6394a90a90f42025-06-18WarningsExact identifier
unii: 3J50XA376E

Reported adverse events (FAERS/openFDA)#

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