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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ClearCanal Ear Wax Softerner Drops CARBAMIDE PEROXIDE NeilMed Pharmaceuticals, Inc. 0ef2be5b-cc39-48ae-b5c5-e787464dea08 2026-08-17 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 54dc3642-0b7a-07d8-e063-6294a90ad556 2026-07-22 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 55057e1b-b11e-51b9-e063-6394a90a9fca 2026-07-22 Warnings Exact identifier application number: M014 Freskaro Ear Drops for Swimmers FRESKARO EAR DROPS FOR SWIMMERS Pharma Nobis, LLC 4f724d85-cd38-41da-e063-6394a90a9fd7 2026-07-08 Warnings Exact identifier application number: M014 Macks Dry n Clear EAR DRYING AID McKeon Products Inc 1ea1da54-2412-c25c-e063-6294a90aa264 2026-06-26 Warnings Exact identifier application number: M014 Equate Swimmers Instant Ear Dry EQUATE SWIMMERS INSTANT EAR DRY Walmart Stores, Inc 76b58a7a-48cf-866c-e053-2a91aa0a7e63 2026-06-26 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. c68b40d9-c1d4-4425-8063-50c00299e718 2026-06-10 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. b2a641da-e070-4223-b836-5ca9ffb89f3f 2026-06-10 Warnings Exact identifier application number: M014 Audiologists Choice Earwax Removal System CARBAMIDE PEROXIDE Oaktree Products Inc. c9ad507b-341c-474f-aaa2-3c3a97a30dd8 2026-05-29 Warnings Exact identifier application number: M014 CVS Health Earwax Removal Kit CARBAMIDE PEROXIDE CVS Pharmacy, Inc. f842534c-46dd-42c7-8386-9a03ce16da86 2026-05-29 Warnings Exact identifier application number: M014 Lucid Hearing Earwax Removal Kit and Bulb CARBAMIDE PEROXIDE Hearing Lab Technology LLC 5e09f566-397f-44d6-8ba2-90987765c737 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Amerisource Bergen 89eac1b0-c700-45b5-8478-da53ace72e16 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal CARBAMIDE PEROXIDE Amerisource Bergen d503b10f-85cd-4bb8-9dec-82d651d525fa 2026-05-29 Warnings Exact identifier application number: M014 Meijer Earwax Removal Kit CARBAMIDE PEROXIDE Meijer Distribution Inc. a5f7bd55-55c3-4b0e-a16c-33bbea40536a 2026-05-29 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. d8fd8102-114f-415d-9083-f98a63f9d1b3 2026-05-29 Warnings Exact identifier application number: M014 Menthol Pain Relieving Gel PAIN RELIEVING GEL NeilMed Pharmaceuticals Inc 513a206c-bbf6-3e51-e063-6294a90adf7a 2026-05-07 Warnings Exact identifier application number: M014 ear drops CARBAMIDE PEROXIDE 6.5% Bionpharma Inc. e8bcf92c-ad32-49d5-e053-2995a90ae0c6 2026-04-27 Warnings Exact identifier application number: M014 Freskaro Earwax Removal Aid CARBAMIDE PEROXIDE 6.50% KIT Pharma Nobis, LLC 4f5967ee-bc05-341c-e063-6394a90a35c6 2026-04-15 Warnings Exact identifier application number: M014 GoodSense Ear Wax Removal Kit CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 9a4198d2-cbea-466a-a252-d5c63d9ea0c1 2026-04-09 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 52f733a7-1301-4078-9267-5ce95b006ccc 2026-04-09 Warnings Exact identifier application number: M014
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