Home NDC 55319-991 Family Wellness Athletes Foot Tolnaftate 1 Cream
Product NDC 55319-991
11-digit product format 553190991
Labeler code 55319
Product ID 55319-991_2ef25f71-76b2-a7ef-e063-6294a90a48b4
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form CREAM
Route TOPICAL
Labeler Family Dollar Stores, Inc
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
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 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55319-991-00 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55319-991-00 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55319-991-00 0efc9e666f02…f202fb6c5f17…
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 Family Wellness Athletes Foot Tolnaftate 1 Cream
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 55319-991-00 Family Wellness Athletes Foot Tolnaftate 1 Cream 14 g in 1 TUBE CREAM 14 3 55319-991-00 Family Wellness Athletes Foot Tolnaftate 1 Cream 1 in 1 BOX CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-991 FAMILY WELLNESS ATHLETES FOOT TOLNAFTATE 1 CREAM (TOLNAFTATE) CREAM [FAMILY DOLLAR STORES, INC] 3 Current NDC, 2 package rows 20250226_f72b5bcd-8834-4da9-aa74-78992ec2838f.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 49 · 973 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 55319-991-00 55319099100 1 TUBE in 1 BOX (55319-991-00) / 14 g in 1 TUBE 1 tube 2024-01-01 No No Current