Home NDC 63347-511-03 TINEACIDE
Product NDC 63347-511
Requested package NDC 63347-511-03
11-digit product format 633470511
Labeler code 63347
Product ID 63347-511_7929e269-caee-4126-a9ba-14cbc2dd73d1
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form LIQUID
Route TOPICAL
Labeler Blaine Labs Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-09-19
Substance TOLNAFTATE
Active strength 140 mg/15mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 TINEACIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 140 mg/15mL
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 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 63347-511-03 TINEACIDE 15 mL in 1 BOTTLE LIQUID 15 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63347-511 TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20231222_273eb424-5dc3-40c8-9ea7-2f732cbd11c9.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63347-511-03 63347051103 15 mL in 1 BOTTLE (63347-511-03) 15 ml 2012-09-19 0000-00-00 No No Current