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 37 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 7MICONAZOLE NITRATEH2-Pharma, LLC4bf1a555-a24f-4807-ac13-db19c55cf2802023-01-13WarningsExact identifier
unii: VW4H1CYW1K
Miconazole 7MICONAZOLE NITRATEH2-Pharma, LLC67dc7d38-a663-48d5-9abf-b3bd8dc0eddf2023-01-13WarningsExact identifier
unii: VW4H1CYW1K
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: 8SKN0B0MIM
AKUTURBENZOIC ACID, NITRIC ACID, APIS MELLIFERA, LYTTA VESICATORIA, POPULUS TREMULOIDES BARK, ANEMONE PRATENSIS FLOWERING TOP, GINGER, AND SOLIDAGO VIRGAUREA FLOWERING TOPPEKANA Nautrheilmittel GmbH7facf36e-c26e-4bc3-a4c1-74e9409f25352023-01-11WarningsExact identifier
unii: 8SKN0B0MIM
RENELIXBENZOIC ACID, NITRIC ACID, APIS MELLIFERA, BERBERIS VULGARIS ROOT BARK, COLCHICUM AUTUMNALE BULB, PROTORTONIA CACTI, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CAPSELLA BURSA-PASTORIS TOPPEKANA Naturheilmittel GmbH11a057e9-4b2a-4de0-a7e9-fbd4029bb7a82023-01-11WarningsExact identifier
unii: 8SKN0B0MIM
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
BOLYM-EX DropsBENZOIC ACID, FORMIC ACID, ARISTOLOCHIA CLEMATITIS ROOT, FERULA ASSA-FOETIDA RESIN, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, CALCIUM PHOSPHATE, UNSPECIFIED FORM, CAPSELLA BURSA-PASTORIS, GALIUM APARINE, DAPHNE MEZEREUM BARK, AND PIPER METHYSTICUM ROOTPEKANA Naturheilmittel GmbH77ec6ee5-1c22-4799-b582-1c32056b14ff2022-12-23WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Miconazole 7MICONAZOLE NITRATEQUALITY CHOICE (Chain Drug Marketing Association)68667d2e-d4d0-46e7-9d84-0f23fdac1cf72022-09-30WarningsExact identifier
unii: VW4H1CYW1K
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acidum BenzoicumACIDUM BENZOICUMHahnemann Laboratories, INC.dca1f84c-443f-61ba-e053-2995a90a618a2022-04-14Exact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
OHM Fatigue ReliefACETICUM AC, ADRENAL GLAND, ARNICA, BENZOICUM AC, FERRUM PHOS, FLUORICUM AC, GINSENG, KALI CARB, KALI LOD, KALI MUR, KALI PHOS, LACTICUM AC, PHOSPHORICUM AC, PICRICUM AC.OHM PHARMA INC.419c6315-37de-46b4-8bef-abbeace265b62021-12-29WarningsExact identifier
unii: 8SKN0B0MIM
Benzoicum AcidumBENZOICUM ACIDUMOHM PHARMA INC.93945281-8cd5-44fd-9772-8f291fa1780f2021-12-29WarningsExact identifier
unii: 8SKN0B0MIM
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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