FDA.reportPublic FDA data

Anti-Fungal

Product NDC
87255-008
11-digit product format
872550008
Labeler code
87255
Product ID
87255-008_48679629-b290-0560-e063-6394a90a1969
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-Fungal Shampoo
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Shenzhen Mengyue Technology Co., Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-12
Substance
KETOCONAZOLE
Active strength
1 mg/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-Fungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE1 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
482c0243-1073-f578-e063-6294a90adf5cAvailable on FDA.report

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
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87255-008-01Anti-Fungal300 mL in 1 BOTTLESHAMPOO3002

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 8 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.1d4966d1-02d9-4b70-acc2-88a8190f920c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Pyrithione zincPYRITHIONE ZINCOld East Main Co.f17154e2-1bcf-43f9-b201-e84d374a05912026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.61bf3788-b1e8-4d7e-ac56-cf209ba390852026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCThe Kroger Co.835270e7-ba6a-46e8-a617-f5df1c69d4112026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCThe Kroger Co.837d7a14-b312-4dce-a00a-623b503293782026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCThe Kroger Co.d442e1af-e31a-4de6-b358-52e08aedd7ee2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Clean ApplePYRITHIONE ZINCThe Kroger Co.00eb0594-cfa5-4fdb-aca8-650c109979242026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCWalmart Inc.e4fd5d8b-a916-41c3-b05e-a32dd528f00f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCWalmart Inc.23ad86c0-5a75-4f52-8561-483708d415d62026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCWalmart Inc.2bafcad7-1bb7-168e-e063-6394a90a0b9e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Paul Mitchell DandruffZINC PYRITHIONEJohn Paul Mitchell Systems4bc02aa8-86b1-985e-e063-6294a90aa2672026-02-26WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCH E Bbdf0b3da-db37-4996-b5e5-23cf824d1d1f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCH E B0927361e-a210-4e44-bbe7-fb68b240cf4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCH E B0410f6a6-6602-44fb-b223-586439938e192026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCH E B626933cb-9c84-4f37-943c-2a9bd21fcea52026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCH E B75342eff-6bff-4fed-bd12-381edd2df6812026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffSELENIUM SULFIDEH E B182ca790-0713-412a-9111-c0cf40f20d022026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCBetter Living Brands, LLC03799050-cb2e-4c96-b177-55e6fc145d6b2026-02-23Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCPerrigo Direct, Incc36e18cf-eec0-4972-b3b5-fe3865a438d82026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCMeijer, Inc.34b80460-fcb9-42a8-b120-1558dc5093fa2026-02-19Warnings, Adverse reactionsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87255-008-0187255000801300 mL in 1 BOTTLE (87255-008-01) 300 ml2026-01-12NoNoCurrent