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 38 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basic Care Miconazole 7MICONAZOLE NITRATEAmazon.com Services LLC4a828083-f5a9-46c3-a07a-3d151f1550252021-08-13WarningsExact identifier
unii: VW4H1CYW1K
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
basic care miconazole 3MICONAZOLE NITRATEAmazon.com Services LLCe1457c13-6d35-41b2-b1e8-7e82b647a0c72021-07-26WarningsExact identifier
unii: VW4H1CYW1K
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
HERS Miconazole 3MICONAZOLE NITRATEHims Inc1b2a36fb-48dd-451e-a804-c864be4e53262021-03-04WarningsExact identifier
unii: VW4H1CYW1K
Topco Miconazole 3MICONAZOLE NITRATETopco Associates LLCaef7be88-3cd7-484b-96a3-e9bbeca55e2a2021-02-10WarningsExact identifier
unii: VW4H1CYW1K
MiconazoleMICONAZOLE NITRATEH E B83305fd6-2154-4b1b-aaec-3e2e56708fdb2021-02-09WarningsExact identifier
unii: VW4H1CYW1K
Topcare Miconazole 7MICONAZOLE NITRATETopco Associates LLC351905b1-f78c-4838-a036-23b2bfc775f22021-02-08WarningsExact identifier
unii: VW4H1CYW1K
signature care miconazole 7MICONAZOLE NITRATESafeway2e04ac2d-cfbc-4261-a8f9-03715f819c1c2021-02-08WarningsExact identifier
unii: VW4H1CYW1K
Good Neighbor Pharmacy Miconazole 7MICONAZOLE NITRATEAmerisource Bergen5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec2021-01-27WarningsExact identifier
unii: VW4H1CYW1K
Good Sense Miconazole 7MICONAZOLE NITRATEL Perrigo Company4902029e-47dd-483b-af03-b1b5936e98ea2021-01-27WarningsExact identifier
unii: VW4H1CYW1K
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good sense miconazole 7MICONAZOLE NITRATEL. Perrigo Company090ee644-7f73-4a43-aa5e-bfa74b0d51302021-01-06WarningsExact identifier
unii: VW4H1CYW1K
Careone miconazole 7MICONAZOLE NITRATEAmerican Sales Companyfced0f7f-31b8-4975-836e-3f38c496a4502021-01-06WarningsExact identifier
unii: VW4H1CYW1K
Real ReliefAPIS MELLIFICA, ARNICA MONTANA, BENZOICUM ACIDUM, CAUSTICUM, COLCHICUM AUTUMNALE, NATRUM CARBONICUMGMP Laboratories of America, Inc.b7a1ce34-a996-22cf-e053-2a95a90afa452020-12-29WarningsExact identifier
unii: 8SKN0B0MIM
Sciatica-Back CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.99ea75a9-3250-281b-e053-2a95a90aed452020-12-07WarningsExact identifier
unii: 8SKN0B0MIM
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.99eda7db-ce40-446f-e053-2995a90a95aa2020-12-07WarningsExact identifier
unii: 8SKN0B0MIM
Lymphatic DrainerECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9a633bfa-188c-dd42-e053-2995a90ad3aa2020-12-04WarningsExact identifier
unii: 8SKN0B0MIM
DrainerCYNARA 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.Newton Laboratories, Inc.9a008b9f-5db5-fac0-e053-2995a90a17c62020-12-02WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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