ANTI-DANDRUFF

Product NDC
85593-128
11-digit product format
855930128
Labeler code
85593
Product ID
85593-128_5ac93feb-eb6e-7563-e063-6294a90ad2e0
Type
HUMAN OTC DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Guangzhou ChuanMa International Trading Co.,Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-06
Substance
KETOCONAZOLE
Active strength
1 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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ANTI-DANDRUFF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9400W927IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240812Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ac93feb-eb6d-7563-e063-6294a90ad2e0Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 28 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Anti-Dandruff Conditioner Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.e69319c8-c49c-415b-a7ea-ec6e77fa625c2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Conditioner mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.08330f44-45e2-47cb-bd2e-cef15ba61aee2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.7d9bf611-db24-4915-9b13-b7b36f47711f2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.b05742fe-692f-45a3-9de0-5f3f08642d782024-02-28WarningsExact identifier
application number: M032
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact identifier
application number: M032
amazon basics maximum strength dandruff Anti-dandruffSELENIUM SULFIDEAMAZON.COM SERVICES LLC194e4c51-ff7b-4def-a71d-efa5dfca3efd2024-02-26WarningsExact identifier
application number: M032
Doo Gro Braids Twists Locs Dandruff Control MoisturizingSALICYLIC ACIDJ. Strickland and Co.116f4f0d-66c7-49dd-e063-6394a90ab2b52024-02-15WarningsExact identifier
application number: M032
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLCada1be0c-53a7-443c-bc3c-f7a26b5f96a92024-02-05WarningsExact identifier
application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.6440fdd9-daa8-4f15-bdee-33724993bd7b2024-02-01WarningsExact identifier
application number: M032
Equate Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.4c84a67a-1f43-4f40-a172-271de7e767852024-01-29WarningsExact identifier
application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c85095f2-5dbd-4822-a83a-dc3641c4a3302024-01-29WarningsExact identifier
application number: M032
HydrocortisoneANTIPRURITIC (ANTI-ITCH)Dynarex Corporation81dff9df-6f7e-49f0-e053-2a91aa0af7e72024-01-23WarningsExact identifier
application number: M032
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company42cc63ab-6f79-4544-8529-7b8c36021b182024-01-22WarningsExact identifier
application number: M032
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.1f4c23d5-ca00-4387-abc7-59d9ef4719772024-01-22WarningsExact identifier
application number: M032
Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company7f681386-976c-40f4-8b18-97413989ab782024-01-22WarningsExact identifier
application number: M032
Prosoria MedicatedSELENIUM SULFIDENuvothera, Inc.44eaaeb0-1400-4697-85d0-e8c2282c1cba2024-01-11WarningsExact identifier
application number: M032
Prosoria ScalpSALICYLIC ACIDNuvothera, Inc.52a98715-3e57-4b86-b91e-0ce433dc22bd2024-01-10WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.f94f4481-c58e-4555-9863-cbaa2c4cdd072024-01-10WarningsExact identifier
application number: M032
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.408d57e4-a707-4826-a04c-99517dc9b5af2024-01-04WarningsExact identifier
application number: M032
Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.986ac1ab-c7c3-40df-b41b-6f26cce22a432024-01-04WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85593-128-0185593012801230 mL in 1 BOTTLE (85593-128-01) 230 ml2026-09-06NoNoCurrent