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 31 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
unii: VW4H1CYW1K
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
unii: VW4H1CYW1K
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: 8SKN0B0MIM
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE,Deseret Biologicals, Inc.e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf2024-09-06WarningsExact identifier
unii: 8SKN0B0MIM
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
unii: VW4H1CYW1K
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
MRCLCINNAMON BARK ESSENTIAL OIL, CLOVE BUD ESSENTIAL OIL, EUCALYPTUS ESSENTIAL OIL, LEMON ESSENTIAL OIL, WILD ROSEMARY ESSENTIAL OILChi Research, Inc.8d12618b-9c8d-4cd6-9218-14395ee0620a2024-07-16WarningsExact identifier
unii: XE54U569EC
unii: 578389D6D0
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
unii: VW4H1CYW1K
THERA Antifungal BodyMICONAZOLE NITRATEMcKesson Medical-Surgical Inc.31096041-28c9-4b16-bbd1-dbadefd375052024-06-14WarningsExact identifier
unii: VW4H1CYW1K
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
unii: VW4H1CYW1K
Miconazole 7MICONAZOLE NITRATEQUALITY CHOICE (Chain Drug Marketing Association)84bef1d3-e4f8-4769-8f94-5ae91ddc95372024-06-06WarningsExact identifier
unii: VW4H1CYW1K
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
unii: VW4H1CYW1K
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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