Home NDC 69771-165 GeriGentle Miconazole nitrate
Product NDC 69771-165
11-digit product format 697710165
Labeler code 69771
Product ID 69771-165_6ff1ce91-f486-4701-ae08-909da151b402
Type HUMAN OTC DRUG
Nonproprietary name Antifungal
Dosage form POWDER
Route TOPICAL
Labeler GERI-GENTLE CORPORATION
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-19
Marketing end 2028-06-30
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
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 GeriGentle Miconazole nitrate Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998461 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69771-165-03 GeriGentle Miconazole nitrate 85 g in 1 BOTTLE, PLASTIC POWDER 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69771-165 GERIGENTLE MICONAZOLE NITRATE (ANTIFUNGAL) POWDER [GERI-GENTLE CORPORATION] 2 Current NDC, 1 package rows 20240627_0ae03b4a-06c8-ddf9-e063-6294a90ad105.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 40 of 49 · 973 matching rows.
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 69771-165-03 69771016503 85 g in 1 BOTTLE, PLASTIC (69771-165-03) 85 g 2022-08-19 2028-06-30 No No Historical