Extended topical sprays for men

Product NDC
84260-010
11-digit product format
842600010
Labeler code
84260
Product ID
84260-010_499840b7-9fb1-f60b-e063-6294a90a0ab8
Type
HUMAN OTC DRUG
Nonproprietary name
CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Lvying Biotechnology Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-13
Substance
CLOVE; CNIDIUM MONNIERI WHOLE; CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE; ZANTHOXYLUM BUNGEANUM FRUIT
Active strength
2.8; 1.2; 9.5; .6 g/100mL; g/100mL; g/100mL; g/100mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extended topical sprays for men
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOVE2.8 g/100mL
CNIDIUM MONNIERI WHOLE1.2 g/100mL
CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE9.5 g/100mL
ZANTHOXYLUM BUNGEANUM FRUIT.6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK48IKT5321, GYR30735RE, 4AF9K48H9O, 3CIP16A418

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84260-010-01Extended topical sprays for men1 mL in 1 BOTTLELIQUID13
84260-010-02Extended topical sprays for men5 mL in 1 BOTTLELIQUID53
84260-010-03Extended topical sprays for men10 mL in 1 BOTTLELIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84260-010EXTENDED TOPICAL SPRAYS FOR MEN (CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE) LIQUID [GUANGZHOU LVYING BIOTECHNOLOGY CO., LTD]1Current NDC, 3 package rows20250328_30101650-2bd1-6ab0-e063-6394a90a28c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84260-010-01842600010011 mL in 1 BOTTLE (84260-010-01) 1 ml2025-03-14NoNoHistorical
84260-010-02842600010025 mL in 1 BOTTLE (84260-010-02) 5 ml2025-03-14NoNoHistorical
84260-010-038426000100310 mL in 1 BOTTLE (84260-010-03) 10 ml2025-03-14NoNoHistorical