Home NDC 84260-011 Antibacterial gel for men
Product NDC 84260-011
11-digit product format 842600011
Labeler code 84260
Product ID 84260-011_300f8e68-db07-c74e-e063-6294a90ad4c7
Type HUMAN OTC DRUG
Nonproprietary name CLOVE,SOPHORA FLAVESCENS ROOT,POLYAMINOPROPYL BIGUANIDE
Dosage form GEL
Route TOPICAL
Labeler Guangzhou Lvying Biotechnology Co.,Ltd
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-26
Substance CLOVE; POLYAMINOPROPYL BIGUANIDE; SOPHORA FLAVESCENS ROOT
Active strength 5; .035; 10 g/100g; g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Antibacterial gel for men
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOVE 5 g/100g POLYAMINOPROPYL BIGUANIDE .035 g/100g SOPHORA FLAVESCENS ROOT 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K48IKT5321 Internal UNII lookup DT9D8Z79ET Internal UNII lookup IYR6K8KQ5K Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84260-011-01 Antibacterial gel for men 3 g in 1 TUBE GEL 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84260-011 ANTIBACTERIAL GEL FOR MEN (CLOVE,SOPHORA FLAVESCENS ROOT,POLYAMINOPROPYL BIGUANIDE) GEL [GUANGZHOU LVYING BIOTECHNOLOGY CO.,LTD] 1 Current NDC, 1 package rows 20250328_300f8e68-db06-c74e-e063-6294a90ad4c7.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 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84260-011-01 84260001101 3 g in 1 TUBE (84260-011-01) 3 g 2025-03-26 No No Current