Home NDC 76348-401-01 Molecular AF
Product NDC 76348-401
Requested package NDC 76348-401-01
11-digit product format 763480401
Labeler code 76348
Product ID 76348-401_2d3f2f5e-be56-71e9-e063-6294a90a6ac2
Type HUMAN OTC DRUG
Nonproprietary name tolnaftate
Dosage form OIL
Route TOPICAL
Labeler Renu Laboratories, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-07-01
Substance TOLNAFTATE
Active strength .01 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Molecular AF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE .01 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1362937 Internal RxNorm lookup 1362942 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-401-01 Molecular AF 11.5 mL in 1 BOTTLE OIL 11.5 4 76348-401-02 Molecular AF 11.5 mL in 1 BOX OIL 11.5 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOLNAFTATE ACTIVE INGREDIENT 06KB629TKV MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 TOLNAFTATE ACTIVE MOIETY 06KB629TKV MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 CINNAMON OIL INACTIVE INGREDIENT E5GY4I6YCZ MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 DIETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT A1A1I8X02B MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 ETHYL MACADAMIATE INACTIVE INGREDIENT ANA2NCS6V1 MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-401 MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250206_1b47e687-29cf-48ce-8bc3-ac8f44f05baa.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 42 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tolnaftate TOLNAFTATE Sheffield Pharmaceuticals LLC ca52af37-c3a2-414c-a24a-a37a92925133 2025-02-20 Warnings Exact identifier application number: M005 Dr Sheffield Athletes Foot CLOTRIMAZOLE Sheffield Pharmaceuticals LLC b8b8e6b2-1022-4592-91ba-3cf94c7cf318 2025-02-19 Warnings Exact identifier application number: M005 UKVOA Toenail Fungus Treatment TOLNAFTATE 1% FUNGI NAIL Jiashen International Trade Limited 2e3cde7b-850e-f9d2-e063-6394a90adb18 2025-02-16 Warnings Exact identifier application number: M005 UKOVA FOOT ODOR PROBIOTIC TOLNAFTATE 1% FUNGI NAIL Jiashen International Trade Limited 2de0225d-dd85-e2da-e063-6294a90a050b 2025-02-11 Warnings Exact identifier application number: M005 Dr. Scholls Instant Cool Athletes Foot Wipes TOLNAFTATE Cosco International, Inc. cde656a9-7841-4a73-a2f4-f5a76a3e15c1 2025-02-06 Warnings Exact identifier application number: M005 Silka Athletes Foot MICONAZOLE NITRATE Genomma Lab USA 307104a2-2df6-43b0-bf3f-f4d93d3e40f1 2025-02-05 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate MICONAZOLE NITRATE NuCare Pharmaceuticals,Inc. fd7dd2eb-03a7-ef1f-e053-6294a90a8557 2025-02-04 Warnings Exact identifier application number: M005 Molecular AF TOLNAFTATE Renu Laboratories, LLC 1b47e687-29cf-48ce-8bc3-ac8f44f05baa 2025-02-03 Warnings Exact identifier application number: M005 ndc (package): 76348-401-01 ndc (product): 76348-401 ndc11 (package): 76348040101 Dermatool Fungal Nail Treatment TOLNAFTATE 1% Papalo Group LLC 2d2c0e12-123d-75bd-e063-6394a90ae546 2025-01-31 Warnings Exact identifier application number: M005 70% Isopropyl Alcohol ISOPROPYL ALCOHOL IDO PHARM d5833c6f-81dd-6ff6-e053-2995a90ac76d 2025-01-30 Warnings Exact identifier application number: M005 AWAS ALCOHOLSPRAY ALCOHOL IDO PHARM 03010837-0289-3e08-e063-6394a90a7d04 2025-01-30 Warnings Exact identifier application number: M005 ELON Dual Defense Anti Fungal Formula UNDECYLENIC ACID Little Giant Holdings LLC 45c4567d-7876-6459-e054-00144ff88e88 2025-01-28 Warnings Exact identifier application number: M005 DCH Labs Antifungal Jock MICONAZOLE NITRATE 2% Derma Care Research Labs, LLC fc749882-2e1e-cad3-e053-6294a90a33ca 2025-01-27 Warnings Exact identifier application number: M005 Antifungal Pen UNDECYLENIC ACID 25% XF Agencija Limited a15d4512-0fc6-424f-9dd3-ab433d9b7a26 2025-01-27 Warnings Exact identifier application number: M005 Mata Hongos UNDECYLENIC ACID Vitamex USA, Corp 21ca7edb-dde3-5846-e063-6394a90a3cc0 2025-01-23 Warnings Exact identifier application number: M005 Povidone Iodine Scrub POVIDONE-IODINE Jianerkang Medical Co., Ltd 53cb4c0d-40b5-4cf3-b122-fd6dd654883f 2025-01-23 Warnings Exact identifier application number: M005 NATUREPLEX TOLNAFTATE ANTIFUNGAL TOLNAFTATE Natureplex, LLC 575b8645-9166-4242-a74f-f4aa4acaaf3d 2025-01-15 Warnings Exact identifier application number: M005 Tobcharm Antifungal Treatment Cream ANTIFUNGAL TREATMENT CREAM Guangzhou Zanming Trading Co., Ltd. 2ba241cc-2767-1190-e063-6294a90ac66b 2025-01-13 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% MICONAZOLE NITRATE Akron Pharma Inc. 8933f939-098a-4257-8d9c-4d5c3240e9a6 2025-01-10 Warnings Exact identifier application number: M005 ANTI-ITCH FEMININE CARE HYDROCORTISONE 0.5% OL PHARMA TECH, LLC Drs PHARMACY d6fa5ff3-ebdc-222d-e053-2a95a90a88d5 2025-01-09 Warnings Exact identifier application number: M005
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76348-401-01 76348040101 11.5 mL in 1 BOTTLE (76348-401-01) 11.5 ml 2011-07-01 No No Current