Home NDC 53943-994 Tolnaftate
Product NDC 53943-994
11-digit product format 539430994
Labeler code 53943
Product ID 53943-994_b7b83259-3dd5-947c-e053-2995a90a2c32
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form CREAM
Route TOPICAL
Labeler Discount Drug Mart, Inc.
Application part333C
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-11-09
Marketing end 0000-00-00
Substance TOLNAFTATE
Active strength 1 g/100g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 14 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 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53943-994-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53943-994-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53943-994-01 557ba5c1ecfa…9c80585c8c6e…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 53943-994-01 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 53943-994-01 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 53943-994-01 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53943-994-01 e2bbac7714bc…27bdfed8d636…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOLNAFTATE ACTIVE INGREDIENT 06KB629TKV TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 TOLNAFTATE ACTIVE MOIETY 06KB629TKV TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 CHLOROCRESOL INACTIVE INGREDIENT 36W53O7109 TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA INACTIVE INGREDIENT 1211AIM8G7 TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 PARAFFIN INACTIVE INGREDIENT I9O0E3H2ZE TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TOLNAFTATE CREAM [DISCOUNT DRUG MART, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53943-994-01 53943099401 1 TUBE in 1 BOX (53943-994-01) > 28.3 g in 1 TUBE 1 tube 2015-11-09 0000-00-00 No No Current