Home NDC 80489-002 Clotrimazole
Product NDC 80489-002
11-digit product format 804890002
Labeler code 80489
Product ID 80489-002_2b522583-1d23-f3bb-e063-6394a90a76a7
Type HUMAN OTC DRUG
Nonproprietary name Drs. Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler OL PHARMA TECH,LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-01
Substance CLOTRIMAZOLE
Active strength 10 mg/g
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 · 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 80489-002-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 80489-002-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 80489-002-01 bd6a592717d7…303034d00443…
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 10 mg/g
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 80489-002-01 Clotrimazole 1 in 1 CARTON CREAM 1 4 80489-002-01 Clotrimazole 28.3 g in 1 TUBE CREAM 28.3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-002 CLOTRIMAZOLE (DRS. CLOTRIMAZOLE) CREAM [OL PHARMA TECH,LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250112_b0e9fc77-6d5c-2472-e053-2995a90a3de4.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 39 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Terrasil Anti-Fungal Treatment MAX CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions db356cc8-f473-4eb2-b8d8-72606fca9dc0 2025-05-23 Warnings Exact identifier application number: M005 terrasil Folliculitis Cream Maximum Strength CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d54756-00dd-bbe1-e063-6394a90a9e02 2025-05-23 Warnings Exact identifier application number: M005 Paume Moisturizing Antibacterial Hand Gel ALCOHOL Paume Inc b6fe12bf-6430-5861-e053-2a95a90a6c8f 2025-05-22 Warnings Exact identifier application number: M005 Tolnaftate Cream 1% ANTIFUNGAL TOLNAFTATE Trifecta Pharmaceuticals Usa Llc 96a40ccd-17f7-4e4e-98da-207802fa2b2d 2025-05-15 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Cardinal Health 110 dba LEADER 34f4c733-2eb2-0db0-e063-6394a90a6431 2025-05-13 Warnings Exact identifier application number: M005 Dr CANUSO fungal nail eraser TOLNAFTATE OIL Renu Laboratories, LLC 2083f9ed-09d6-26e6-e054-00144ff88e88 2025-05-13 Warnings Exact identifier application number: M005 Dr. Canuso foot repair serum TOLNAFTATE SERUM Renu Laboratories, LLC 1fcc52c5-7030-13cb-e054-00144ff8d46c 2025-05-13 Warnings Exact identifier application number: M005 Private Label Antifungal Barrier Cream MICONAZOLE NITRATE ANTIFUNGAL CREAM Swiss-American CDMO, LLC 2ee40c37-504b-43ed-960a-535015407492 2025-05-09 Warnings Exact identifier application number: M005 Osimoon Fungal Nail Treatment Kit OSIMOON FUNGAL NAIL TREATMENT KIT Guangzhou Zanming Trading Co., Ltd. 34aec10d-a0d0-d956-e063-6394a90a39b2 2025-05-09 Warnings Exact identifier application number: M005 ANTIFUNGAL MICONAZOLE VIVE HEALTH LLC 33d9c724-d4c4-2597-e063-6294a90aa5f3 2025-04-28 Warnings Exact identifier application number: M005 ANTIFUNGAL CLOTRIMAZOLE VIVE HEALTH LLC 33db98f5-f6d9-742a-e063-6394a90a2a03 2025-04-28 Warnings Exact identifier application number: M005 Foot Cure Nail Repair Pen ANTIFUNGAL NAIL REPAIR PEN SANSAR, LLC 9c823e27-8bb3-4ccd-bf7e-a99d45908e88 2025-04-25 Warnings Exact identifier application number: M005 WISH HAND SANITIZER CUCUMBER MELON ALCOHOL HAND SANITIZER PT SUPER HOME PRODUCT INDONESIA 3380404d-9499-e9fb-e063-6394a90a0f27 2025-04-24 Warnings Exact identifier application number: M005 WISH HAND SANITIZER SWEET GUAVA FRESH COCONUT ALCOHOL HAND SANITIZER PT SUPER HOME PRODUCT INDONESIA 3380fe6d-e059-401a-e063-6394a90a787a 2025-04-24 Warnings Exact identifier application number: M005 WISH HAND SANITIZER DRAGONFRUIT JASMINE ALCOHOL HAND SANITIZER PT SUPER HOME PRODUCT INDONESIA 3381cefb-281c-9b85-e063-6294a90acfd9 2025-04-24 Warnings Exact identifier application number: M005 Wish Hand Sanitizer Coconut Cream White Florals ALCOHOL HAND SANITIZER PT SUPER HOME PRODUCT INDONESIA 33826aef-6e50-2730-e063-6394a90a727b 2025-04-24 Warnings Exact identifier application number: M005 WISH HAND SANITIZER GOLDEN CITRUS ALCOHOL HAND SANITIZER PT SUPER HOME PRODUCT INDONESIA 3391a78e-525d-c2ba-e063-6394a90a1e99 2025-04-24 Warnings Exact identifier application number: M005 WISH HAND SANITIZER SALTED CARAMEL PISTACHIO ALCOHOL HAND SANITIZER PT SUPER HOME PRODUCT INDONESIA 33927939-a9dc-ab67-e063-6394a90a71cc 2025-04-24 Warnings Exact identifier application number: M005 WISH HAND SANITIZER BLACK PLUM VANILLA ALCOHOL HAND SANITIZER PT. SUPER HOME PRODUCT INDONESIA 336c751f-6a33-ca55-e063-6394a90a9749 2025-04-23 Warnings Exact identifier application number: M005 WISH HAND SANITIZER VIOLET ORCHID SANDALWOOD ALCOHOL HAND SANITIZER PT. SUPER HOME PRODUCT INDONESIA 337e4526-238a-bc2d-e063-6394a90a5a27 2025-04-23 Warnings Exact identifier application number: M005
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 80489-002-01 80489000201 1 TUBE in 1 CARTON (80489-002-01) / 28.3 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current