COOLKESI BOTIN SHAM-POO

Product NDC
84507-039
11-digit product format
845070039
Labeler code
84507
Product ID
84507-039_3743b587-9e8e-edc2-e063-6394a90a2981
Type
HUMAN OTC DRUG
Nonproprietary name
hair care
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Guangdong Miaolian Cosmetics Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-11
Substance
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL; ROSA DAMASCENA FLOWER OIL; ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL
Active strength
.1; .1; .1 mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COOLKESI BOTIN SHAM-POO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL.1 mg/100mL
ROSA DAMASCENA FLOWER OIL.1 mg/100mL
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL.1 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVIF565UC2G, 18920M3T13, 8LGU7VM393

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84507-039-01COOLKESI BOTIN SHAM-POO500 mL in 1 BOTTLESHAMPOO5001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84507-039-0184507003901500 mL in 1 BOTTLE (84507-039-01) 500 ml2025-06-11NoNoHistorical