Home NDC 75983-002 First Aid Antifungal Medicated
Product NDC 75983-002
11-digit product format 759830002
Labeler code 75983
Product ID 75983-002_d8c3138a-cad7-fb0f-e053-2a95a90a4a53
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form CREAM
Route TOPICAL
Labeler First Aid Research Corp.
Application part333C
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-01-02
Marketing end 0000-00-00
Substance TOLNAFTATE
Active strength 10 mg/g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 75983-002 I Inactivated by FDA 2026-07-31 excluded product product 75983-002 I Inactivated by FDA 2026-07-31 excluded package package 75983-002 75983-002-28 I Inactivated by FDA 2026-07-31 excluded package package 75983-002 75983-002-02 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Flammable: Keep away from fire or flame. Do not use on children under 2 years of age unless directed by a doctor. If pregnant or breastfeeding ask a health professional before use. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs. there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75983-002-01 First Aid Antifungal Medicated 28 g in 1 TUBE CREAM 28 3 75983-002-02 First Aid Antifungal Medicated 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75983-002 FIRST AID ANTIFUNGAL MEDICATED (TOLNAFTATE) CREAM [FIRST AID RESEARCH CORP.] 3 Legacy NDC, 2 package rows 20220225_b7ae2f6f-bae3-573a-e053-2a95a90a7fa0.zip
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 75983-002-01 75983000201 28 g in 1 TUBE 28 g Historical 75983-002-02 75983000202 1 TUBE in 1 CARTON (75983-002-02) > 28 g in 1 TUBE (75983-002-01) 1 tube 2020-01-01 0000-00-00 No No Current