Home NDC 69771-165 GeriGentle Miconazole nitrate
Product NDC 69771-165
11-digit product format 697710165
Labeler code 69771
Product ID 69771-165_422963ab-509d-6688-e063-6394a90af529
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
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Do not use : ■On children under 2 years of age unless directed by a doctor ■For diaper rash When using this product avoid contact with the eyes Stop use and ask a doctor if ■Irritation occurs ■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 Identifiers# Field, Values table Field Values Unii VW4H1CYW1K Rxcui 998461
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
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