Home NDC 76348-401 Molecular AF
Product NDC 76348-401
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-401-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-401-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-401-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-401-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-401-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-401-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76348-401-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76348-401-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76348-401-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76348-401-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76348-401-02 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76348-401-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76348-401-02 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76348-401-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76348-401-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76348-401-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76348-401-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76348-401-01 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 8 of 51 · 1,004 matching rows.
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 76348-401-02 76348040102 11.5 mL in 1 BOX (76348-401-02) 11.5 ml 2011-07-01 No No Current