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 39 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DetoxifierURICUM ACIDUM, BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM.,PTELEA,TARAXACUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGONewton Laboratories, Inc.92ad49e0-2cfe-7d51-e053-2995a90a16f52020-11-24WarningsExact identifier
unii: 8SKN0B0MIM
Miconazole NitrateMICONAZOLE NITRATEActavis Pharma, Inc.aa9e250b-f317-42cb-b8d2-e85de56f4ef72020-10-21Adverse reactionsExact identifier
unii: VW4H1CYW1K
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
DrainageCYNARA 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, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Xymogena526f4ac-1630-c122-e053-2995a90a6a272020-05-08WarningsExact identifier
unii: 8SKN0B0MIM
MPBERBERIS VULGARIS, ISATIS TINCTORIA, MORINDA CITRIFOLIA, PETIVERIA TETRANDRA, SCHINUS MOLLE, THYMOLUM, UVA-URSIChi Research, Inc.4b8bb332-a718-47a9-970d-299324309bee2020-03-03WarningsExact identifier
unii: 3J50XA376E
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b44b452d-3630-4cb5-8ed1-1f8edac4690c2018-08-15Warnings, Adverse reactionsExact identifier
unii: VW4H1CYW1K
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b026bc7d-3a18-41e8-88c4-1e063cd2f42c2018-08-14Warnings, Adverse reactionsExact identifier
unii: VW4H1CYW1K
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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