antibacterial gel for men (84260-011)

Drug Facts

Product Profile

Brand Name antibacterial gel for men

Generic Name clove,sophora flavescens root,polyaminopropyl biguanide

Labeler guangzhou lvying biotechnology co.,ltd

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

clove 5 g/100g, polyaminopropyl biguanide .035 g/100g, sophora flavescens root 10 g/100g

Manufacturer

Guangzhou Lvying Biotechnology Co.,Ltd

Identifiers & Regulatory

Product NDC 84260-011

Product ID 84260-011_300f8e68-db07-c74e-e063-6294a90ad4c7

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number 505G(a)(3)

Listing Expiration 2026-12-31

Marketing Start 2025-03-26

Pharmacologic Class

Established (EPC)

non-standardized plant allergenic extract [epc] non-standardized food allergenic extract [epc]

Chemical Structure

allergens [cs] dietary proteins [cs] plant proteins [cs] food additives [cs]

Physiologic Effect

increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84260011

Hyphenated Format 84260-011

Supplemental Identifiers

UNII

K48IKT5321 DT9D8Z79ET IYR6K8KQ5K

NUI

N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0008672

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name antibacterial gel for men (source: ndc)

Generic Name clove,sophora flavescens root,polyaminopropyl biguanide (source: ndc)

Application Number 505G(a)(3) (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

5 g/100g
.035 g/100g
10 g/100g

source: ndc

Packaging

3 g in 1 TUBE (84260-011-01)

source: ndc

Packages (1)

84260-011-01 3 g in 1 TUBE (84260-011-01)

Ingredients (3)

clove (5 g/100g) polyaminopropyl biguanide (.035 g/100g) sophora flavescens root (10 g/100g)

Linked Drug Pages (1)

Antibacterial gel for men ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "300f8e68-db07-c74e-e063-6294a90ad4c7", "openfda": {"nui": ["N0000185375", "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0008672"], "unii": ["K48IKT5321", "DT9D8Z79ET", "IYR6K8KQ5K"], "spl_set_id": ["300f8e68-db06-c74e-e063-6294a90ad4c7"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Food Additives [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Plant Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]"], "manufacturer_name": ["Guangzhou Lvying Biotechnology Co.,Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 g in 1 TUBE (84260-011-01)", "package_ndc": "84260-011-01", "marketing_start_date": "20250326"}], "brand_name": "Antibacterial gel for men", "product_id": "84260-011_300f8e68-db07-c74e-e063-6294a90ad4c7", "dosage_form": "GEL", "pharm_class": ["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]"], "product_ndc": "84260-011", "generic_name": "CLOVE,SOPHORA FLAVESCENS ROOT,POLYAMINOPROPYL BIGUANIDE", "labeler_name": "Guangzhou Lvying Biotechnology Co.,Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antibacterial gel for men", "active_ingredients": [{"name": "CLOVE", "strength": "5 g/100g"}, {"name": "POLYAMINOPROPYL BIGUANIDE", "strength": ".035 g/100g"}, {"name": "SOPHORA FLAVESCENS ROOT", "strength": "10 g/100g"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}