FDA.reportPublic FDA data

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
IngredientStrength
CLOVE5 g/100g
POLYAMINOPROPYL BIGUANIDE.035 g/100g
SOPHORA FLAVESCENS ROOT10 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK48IKT5321, DT9D8Z79ET, IYR6K8KQ5K

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84260-011-01Antibacterial gel for men3 g in 1 TUBEGEL31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84260-011ANTIBACTERIAL GEL FOR MEN (CLOVE,SOPHORA FLAVESCENS ROOT,POLYAMINOPROPYL BIGUANIDE) GEL [GUANGZHOU LVYING BIOTECHNOLOGY CO.,LTD]1Current NDC, 1 package rows20250328_300f8e68-db06-c74e-e063-6294a90ad4c7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84260-011-01842600011013 g in 1 TUBE (84260-011-01) 3 g2025-03-26NoNoHistorical