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 14 of 39 · 776 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.60d8a79c-82a4-4312-b7c8-519e2000bc8e2026-02-03Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Eucalyptol, menthol, methyl salicylate, thymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDemoulas Super Markets, Inc51748426-047a-4ecf-b0fe-205667c9ef082026-02-03Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Yimimde Tinea Versicolor ReliefYIMIMDE TINEA VERSICOLOR RELIEFShenzhen Ishan Technology Co., Ltd49f88ab5-2409-1b4c-e063-6394a90a5d692026-02-03WarningsExact identifier
unii: VIF565UC2G
MARIANP FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.49d1dbc4-91be-1f5c-e063-6394a90a55ec2026-02-02WarningsExact identifier
unii: VIF565UC2G
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
iShanCare Ringworm CleansingISHANCARE RINGWORM CLEANSINGShenzhen Ishan Technology Co., Ltd49d2c46b-c863-1bf9-e063-6294a90a0caf2026-02-02WarningsExact identifier
unii: VIF565UC2G
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.06755465-7a74-40f8-9dd4-dbe24b8fec2a2026-02-02Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49e45462-a05f-d370-e063-6394a90a1e0f2026-02-02WarningsExact identifier
unii: VIF565UC2G
iShanCare Balanitis CleansingISHANCARE BALANITIS CLEANSINGShenzhen Ishan Technology Co., Ltd49cb3716-9d73-8297-e063-6394a90a0d6c2026-02-01WarningsExact identifier
unii: VIF565UC2G
iShanCare Folliculitis CleansingISHANCARE FOLLICULITIS CLEANSINGShenzhen Ishan Technology Co., Ltd49cbba59-a25d-eb9f-e063-6394a90a8a8b2026-02-01WarningsExact identifier
unii: VIF565UC2G
Antiseptic Mouth RinseEUCALYPTOLRite Aid Corporation0f41f4fa-bfcc-4ae7-b173-52a0a9a6366c2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Oral Care AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRite Aid Corporationc15b31be-a662-4c22-b4a7-66baed20868a2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRite Aid Corporationd55d4101-be0c-47d9-a2ad-d3d30516bf042026-01-30Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRite Aid Corporationa21eef4f-62a5-4f40-8a52-dd581577f7f92026-01-30Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL7-Eleven5625ac4e-aa37-41b5-80b7-67b223707ccf2026-01-29Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAldi, Inc08aef3fa-f863-4716-ac72-1d7bfcc0d6ef2026-01-29Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAMERISOURCE BERGEN02ffe892-732b-4798-9ea8-ca646c37f3002026-01-29Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCardinal Health, 110 dba Leaderd176eebb-4870-4206-a52e-f581ecaff4002026-01-29Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International4ca91b34-a3ba-4c23-8bfb-473342ac42a22026-01-29Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International98471185-3798-412f-b9b4-47f1971fbc7c2026-01-29Warnings, Adverse reactionsExact identifier
unii: 3J50XA376E
unii: RV6J6604TK

Reported adverse events (FAERS/openFDA)#

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