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 18 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: 8SKN0B0MIM
NAIL TREATMENT Oil ElixirsTEA TREE OILGuangzhou Mizi Biotechnology Co., LTD.44913371-df05-05a9-e063-6294a90a5d202025-12-17WarningsExact identifier
unii: VIF565UC2G
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
unii: VW4H1CYW1K
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC1ea56ac9-4fc2-41c0-adda-5a2c55bef6962025-12-10WarningsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
BIOCENCEEUCALYPTOL, THYMOLBio-Germ Protection LLC9e8165f4-17b5-4d49-87ea-4926b687a2352025-12-10WarningsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLCc4f5d7b1-dbc0-4595-a3df-228710a3d1662025-12-10WarningsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC847b9edc-74e6-43fd-83cd-43e6712780c62025-12-10WarningsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
ELAIMEI FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.457d08eb-e812-8f12-e063-6294a90ab85f2025-12-10WarningsExact identifier
unii: VIF565UC2G
Lofuanna FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.43da9ec2-5f2f-dfce-e063-6394a90aecca2025-12-10WarningsExact identifier
unii: VIF565UC2G
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
unii: VW4H1CYW1K
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact identifier
unii: VW4H1CYW1K
BM ArnicaARNICA MONTANABM Private Limited450d5924-0d5d-e013-e063-6394a90a76bb2025-12-05WarningsExact identifier
unii: 578389D6D0
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer Healthcare LLC.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
unii: VW4H1CYW1K
Lotrimin AF DeodorantMICONAZOLE NITRATEBayer HealthCare LLC.0bee54eb-df2f-15fe-e063-6294a90a2fd22025-12-04WarningsExact identifier
unii: VW4H1CYW1K
Lotrimin AFMICONAZOLE NITRATEBayer Healthcare LLC.163996c6-af54-21ac-e063-6394a90ac05c2025-12-04WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions23ca78c0-16a9-455c-99a7-b9a9a3affa602025-12-03WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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