FDA.reportPublic FDA data

Pureskin Scalp Protection anti dandruff shampoo.

Product NDC
83887-004
11-digit product format
838870004
Labeler code
83887
Product ID
83887-004_2d38d7f4-6c9a-182d-e063-6294a90a7b33
Type
HUMAN OTC DRUG
Nonproprietary name
Pureskin Scalp Protection anti dandruff shampoo
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Changsha Beiliang E-commerce Co., Ltd
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
KETOCONAZOLE
Active strength
.5 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pureskin Scalp Protection anti dandruff shampoo.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE.5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui425918

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83887-004-01Pureskin Scalp Protection anti dandruff shampoo.300 mL in 1 BOTTLESHAMPOO3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83887-004PURESKIN SCALP PROTECTION ANTI DANDRUFF SHAMPOO. (PURESKIN SCALP PROTECTION ANTI DANDRUFF SHAMPOO) SHAMPOO [CHANGSHA BEILIANG E-COMMERCE CO., LTD]1Current NDC, 1 package rows20250205_2d38d7f4-6c99-182d-e063-6294a90a7b33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
425918ketoconazole 0.5 % Medicated ShampooPSN2d38d7f4-6c99-182d-e063-6294a90a7b331
425918ketoconazole 5 MG/ML Medicated ShampooSCD2d38d7f4-6c99-182d-e063-6294a90a7b331
425918ketoconazole 0.5 % Medicated ShampooSY2d38d7f4-6c99-182d-e063-6294a90a7b331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83887-004-0183887000401300 mL in 1 BOTTLE (83887-004-01) 300 ml2025-02-03NoNoCurrent