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 27 of 41 · 817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blood LiquescenceALLIUM CEPA, HYSSOPUS OFFICINALIS, AVENA SATIVA, PALOONDO, URTICA DIOICA, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALE, CAPSICUM ANNUUM, HEPAR (BOVINE), HYPOPHYSIS SUIS, JUGLANS REGIA, MEDULLA OSSIS SUIS, REMEX CRISPUS, SPLEEN (BOVINE), CAMPHORA, MAGNESIA PHOSPHORICA, FERRUM PHOSPHORICUM, PYROGENIUMNutritional Specialties, Inc.42f57741-8d47-4e50-a8fb-adfc73453ed22025-09-22WarningsExact identifier
unii: N20HL7Q941
I-SleepABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANANewton Laboratories, Inc.c6f053fe-8b59-7226-e053-2995a90a80932025-09-18WarningsExact identifier
unii: N20HL7Q941
OLD TIME Owell Naturals Draw Salve with AloeCAMPHORA HPUS, ALOEOwell Naturals Brand LLC1ce7666a-6f10-b584-e063-6294a90a05602025-09-12WarningsExact identifier
unii: N20HL7Q941
Owell Naturals Draw Salve with Camphor 2.0 oz.CAMPHOROwell Naturals Brand LLC1859acdc-d8d4-52a2-e063-6294a90aff742025-09-12WarningsExact identifier
unii: N20HL7Q941
OLD TIME Owell Naturals Draw Salve with AloeCAMPHORA HPUS, ARNICAOwell Naturals Brand LLC1cebbe4c-0967-a136-e063-6394a90a20452025-09-12WarningsExact identifier
unii: N20HL7Q941
OLD TIME Owell Naturals Draw Salve with AloeCAMPHORA HPUSOwell Naturals Brand LLC1cfc51f4-b1fb-64a8-e063-6294a90a45552025-09-12WarningsExact identifier
unii: N20HL7Q941
equate Athletes FootTOLNAFTATEWal-Mart Stores Ince90297d0-0f87-4ae3-b9b7-959266d57c242025-09-11WarningsExact identifier
unii: 06KB629TKV
DRAWZONE Toenail Fungus Treatment PenTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.3dcdb0c4-e0ec-dfee-e063-6294a90a0bda2025-09-05WarningsExact identifier
unii: 06KB629TKV
ERWCNMIE Toenail Fungus Treatment PenTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.3dce0c33-d4f3-5135-e063-6394a90a85a62025-09-02WarningsExact identifier
unii: 06KB629TKV
Extra Strength Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
unii: 06KB629TKV
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEVALU MERCHANDISERS, CO.1d258684-9034-460c-953d-78e2b51981672025-08-26WarningsExact identifier
unii: 06KB629TKV
Sea Jewels Lemon Balm Full Body SalveMELISSA OFFICINALIS LEAF, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTUS OIL, COCONUT OIL, BEESWAX, ALPHA-TOCOPHEROL ACETATE DL-, FLAX SEED, ARGAN OIL, GRAPE SEED OIL, JOJOBA OIL, ARCTIUM LAPPA ROOT, OREGANOSEAJewels LLC3cd77075-0825-d283-e063-6294a90ae7b52025-08-20WarningsExact identifier
unii: VIF565UC2G
Rapid MicroGelTOLNAFTATEThe Tetra Corporationafb6d7c4-1f75-4694-83c8-d6469250d6a12025-08-19WarningsExact identifier
unii: 06KB629TKV
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
rxcui: 313423
unii: 06KB629TKV
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
rxcui: 313423
unii: 06KB629TKV
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: 6UYK2W1W1E
Gyntima Probiotica ForteSAGE, TEA TREE OIL, FOLIC ACID, LACTIC ACIDFytofontana LLC3c318c24-cc68-5589-e063-6394a90a8d802025-08-12WarningsExact identifier
unii: VIF565UC2G
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
rxcui: 313423
unii: 06KB629TKV
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
unii: 06KB629TKV
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
unii: 06KB629TKV

Reported adverse events (FAERS/openFDA)#

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