Home NDC 68071-4245 Tolnaftate
Product NDC 68071-4245
11-digit product format 680714245
Labeler code 68071
Product ID 68071-4245_1a3c5c49-b376-1318-e063-6394a90a47b6
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-02-11
Substance TOLNAFTATE
Active strength 10 mg/g
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4245-5 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4245-5 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4245-5 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Tolnaftate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 10 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103951 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4245-5 Tolnaftate 14.18 g in 1 TUBE CREAM 14.18 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4245 TOLNAFTATE CREAM [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240701_63665de7-8415-651f-e053-2991aa0ac2bb.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 1 of 7 · 136 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-4245-5 68071424505 14.18 g in 1 TUBE (68071-4245-5) 14.18 g 2018-01-22 0000-00-00 No No Current