FDA.reportPublic FDA data

NDC 76348-995-05 - Nail Renu

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
76348-995
Requested NDC
76348-995-05
Package NDCs from labels
76348-995-05, 76348-995-01
Manufacturer
RENU LABORATORIES, INC.
Effective date
2023-03-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NAIL RENU ANTIFUNGAL SOLUTIONRENU LABORATORIES, INC.2023-03-22HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-995-012025-01-30C16284748780-12cef2736-acf0-d83d-e063-dadaa90ab31fNAIL RENU ANTIFUNGAL SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-995-01Nail Renu1 in 1 BOXSOLUTION11
76348-995-05Nail Renu15 mL in 1 BOTTLE, GLASSSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-995NAIL RENU (TOLNAFTATE 1%) SOLUTION [RENU LABORATORIES, INC.]12 package rows20230406_f1877b83-30fc-7c8f-e053-2a95a90a7d1b.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 41 · 817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MRCLCINNAMON BARK ESSENTIAL OIL, CLOVE BUD ESSENTIAL OIL, EUCALYPTUS ESSENTIAL OIL, LEMON ESSENTIAL OIL, WILD ROSEMARY ESSENTIAL OILChi Research, Inc.d4a7d672-4dce-4ec5-a97c-db0fb8b303e82024-04-22WarningsExact identifier
unii: XE54U569EC
unii: 578389D6D0
Pain Relieving LinimentCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.97a0c839-0927-4e54-aee2-ded2016ac4a02024-04-02WarningsExact identifier
unii: N20HL7Q941
ControlANACARDIUM ORIENTALE, AQUA MARINA, ARGENTUM NITRICUM, ASARUM CANADENSE, BLATTA ORIENTALIS, BUFO RANA, CEREBRUM SUIS, CLEMATIS ERECTA, CUPRUM ACETICUM, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PLACENTA TOTALIS SUIS, RHUS TOX, THUJA OCCIDENTALIS, THYMOLUM, VALERIANA OFFICINALISDeseret Biologicals, Inc.9daec04d-44fb-4d0f-8e21-1109f515eb5d2024-03-25WarningsExact identifier
unii: 3J50XA376E
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.1dc21c95-b419-4175-85f8-040b73060d372024-03-20WarningsExact identifier
unii: N20HL7Q941
Pain Relief Roll-On MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.d94ae654-ce25-4bff-b9bd-24a0e0e8568a2024-03-20WarningsExact identifier
unii: N20HL7Q941
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.f8bff018-fb4f-47b4-b8f8-4a496aede3462024-03-20WarningsExact identifier
unii: N20HL7Q941
Snore-SootheECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICANewton Laboratories, Inc.140a0bcf-82b3-c430-e063-6294a90ad38f2024-03-19WarningsExact identifier
unii: N20HL7Q941
Mycozyl HC Cream GelTOLNAFTATE, HYDROCORTISONEPURETEK CORPORATION137f9cc1-68c6-edcc-e063-6394a90abf6a2024-03-14Warnings, Adverse reactionsExact identifier
unii: 06KB629TKV
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
unii: N20HL7Q941
XtraCare Vaporizing Chest RubCAMPHOR, MENTHOLRejoice Internationalc3e220d6-fff4-452f-99a9-bd701fc608a02024-02-28WarningsExact identifier
unii: N20HL7Q941
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
unii: 06KB629TKV
Pain RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
unii: N20HL7Q941
Menthol Camphor Cough Suppressant Topical Analgesic RubCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.fd0ea70a-ef12-48b1-8d9d-cc5f6417f8542024-02-08WarningsExact identifier
unii: N20HL7Q941
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
unii: N20HL7Q941
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
unii: N20HL7Q941
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: H4N855PNZ1
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
unii: 06KB629TKV
Lung DrainageKALI MURIATICUM, CARBO VEGETABILIS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, PNEUMOCOCCINUM, OXYGENIUM, ANTIMONIUM ARSENICICUM, CAMPHORA, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, IPECACUANHA, LOBELIA PURPURESCENS, PHOSPHORUS, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.8fdb37fb-f3df-4dae-abb4-1f3a71c1c6832024-01-15WarningsExact identifier
unii: N20HL7Q941

Reported adverse events (FAERS/openFDA)#

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