Home NDC 68071-3395 clotrimazole
Product NDC 68071-3395
11-digit product format 680713395
Labeler code 68071
Product ID 68071-3395_1d79b80a-e64c-7d7d-e063-6294a90a82bd
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals, Inc.
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-06-03
Substance CLOTRIMAZOLE
Active strength 1 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 · 8 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 2024-07-10 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 68071-3395-3 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 68071-3395-3 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 68071-3395-3 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 68071-3395-3 1332a3947898…d4bfe170f9cd…
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 clotrimazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309367 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3395-3 clotrimazole 30 g in 1 BOX CREAM 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3395 CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240726_54241254-1d9a-346a-e054-00144ff8d46c.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 6 of 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SuavEar Earwax Removal Aid EARWAX REMOVAL AID NEILMED PHARMACEUTICALS INC c067f1a4-1f67-3f4d-e053-2a95a90a6095 2024-01-11 Warnings Exact identifier application number: M014 Ear Drops Major CARBAMIDE PEROXIDE 6.5% A-S Medication Solutions eb7df1cc-50db-479a-bc1c-dfd7004dd35b 2024-01-08 Warnings Exact identifier application number: M014 Wax B Gone Ear Wax Removal Drops CARBAMIDE PEROXIDE - 6.5% SIGMAR, LLC 3339cac0-8f32-4f71-bef3-dd1524c4b244 2024-01-08 Warnings Exact identifier application number: M014 Ear Drops for Swimmers ISOPROPYL ALCOHOL Pharma Nobis, LLC e42fd693-24ab-0fc0-e053-2995a90ab954 2023-12-26 Warnings Exact identifier application number: M014 LEADER Ear Drops for Swimmers LEADER EAR DROPS FOR SWIMMERS Cardinal Health, 110 dba Leader 874857eb-2a9d-6ef7-e053-2995a90af156 2023-12-22 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Pharma Nobis, LLC e21e114c-99b6-861c-e053-2995a90aeac1 2023-12-22 Warnings Exact identifier application number: M014 Quality Choice Instant Ear Dry ISOPROPYL ALCOHOL Chain Drug Manufacturing Association 9d3c681b-a941-6ddb-e053-2a95a90ad3bf 2023-12-20 Warnings Exact identifier application number: M014 Premiere Value Ear Drops for Swimmers ISOPROPYL ALCOHOL Pharmacy Value Alliance; LLC 9d606fe6-ae57-724f-e053-2a95a90abffe 2023-12-20 Warnings Exact identifier application number: M014 CVS Ear Drops for Swimmers ISOPROPYL ALCOHOL CVS Pharmacy cc4614ee-5d6e-4a07-9826-aff12cc35abd 2023-12-20 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Randob Labs, Ltd. a9904b63-27a4-205c-e053-2995a90af762 2023-12-19 Warnings Exact identifier application number: M014 DDM Ear Drops for Swimmers ISOPROPYL ALCOHOL Discount Drug Mart 5d565cbc-874b-41dc-e053-2991aa0a6787 2023-12-19 Warnings Exact identifier application number: M014 TopCare Swimmers Ear Drops ISOPROPYL ALCOHOL TOPCO ASSOCIATES 9dccbc25-d954-f917-e053-2a95a90a0eff 2023-12-18 Warnings Exact identifier application number: M014 HEB Water Drying Aid ISOPROPYL ALCOHOL H E B 5d5741f8-64fd-0a9a-e053-2991aa0a0b5e 2023-12-18 Warnings Exact identifier application number: M014 Best Choice Earwax Removal Kit CARBAMIDE PEROXIDE Valu Merchandisers, Co. f943ac0e-8171-446d-8c6c-69612b482643 2023-12-15 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. ba8d71b5-7f1f-44a5-ac5b-1f7ceeb02875 2023-12-15 Warnings Exact identifier application number: M014 DISCOUNT drug mart FOOD FAIR earwax removal kit CARBAMIDE PEROXIDE Discount Drug Mart 83fdf4d6-3cdf-429d-b53d-80775a35d0c9 2023-12-15 Warnings Exact identifier application number: M014 Discount Drug Mart Earwax Removal Drops CARBAMIDE PEROXIDE Discount Drug Mart e30c943e-bba5-4520-8f83-16bfa29ee1cf 2023-12-15 Warnings Exact identifier application number: M014 HUMCO Ear Drops for Swimmers ISOPROPYL ALCOHOL Humco Holding Group, Inc. 6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b2 2023-12-15 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Humco Holding Group, Inc a8c052d8-fb9c-09f2-e053-2a95a90a37af 2023-12-15 Warnings Exact identifier application number: M014 EAR DRYING AGENT ISOPROPYL ALCOHOL 94.998% GLYCERIN 5% Rite Aid 9b4299af-c1a2-43e6-90d4-25f4c89d1bef 2023-12-15 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 68071-3395-3 68071339503 30 g in 1 BOX (68071-3395-3) 30 g 2017-07-12 0000-00-00 No No Current