FDA.reportPublic FDA data

Nizoral Psoriasis

Product NDC
55505-202
11-digit product format
555050202
Labeler code
55505
Product ID
55505-202_9cc9e4a8-9684-4fb5-8aa7-aedbe2b008f2
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Kramer Laboratories
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
Substance
SALICYLIC ACID
Active strength
3 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55505-202DDiscontinued by firm2026-10-16
excluded packagepackage55505-20255505-202-65DDiscontinued by firm2026-10-16

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
Nizoral Psoriasis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205023Internal RxNorm lookup
2467167Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ad7f931-5411-474b-a86e-b511811b7dc0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-202-64Nizoral Psoriasis325 mL in 1 BOTTLESHAMPOO3255
55505-202-64Nizoral Psoriasis1 in 1 CARTONSHAMPOO15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-202NIZORAL PSORIASIS (SALICYLIC ACID) SHAMPOO [KRAMER LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240830_6ad7f931-5411-474b-a86e-b511811b7dc0.zip
55505-202NIZORAL PSORIASIS (SALICYLIC ACID) SHAMPOO [KRAMER LABORATORIES]1Current NDC, Legacy NDC20240918_21c4a701-7f20-c8b2-e063-6394a90ab10c.zip

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 12 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.482c0243-1073-f578-e063-6294a90adf5c2026-01-15WarningsExact identifier
application number: M032
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDOlympus Trading Company, LLCca9e4168-dfe9-4fb0-b78d-83b9fe5205f82026-01-09WarningsExact identifier
application number: M032
Kenkoderm PsoriasisSALICYLIC ACIDOlympus Trading Company, LLC9143edff-9809-4620-96fe-6293d5b75df82026-01-09WarningsExact identifier
application number: M032
DZUL ANTI-DANDRUFF CONDITIONERPYRITHIONE ZINCCaball Sales, Inc.05f29038-f14f-4285-e063-6294a90ac9802026-01-08WarningsExact identifier
application number: M032
DZUL ANTI-DANDRUFFZINC PYRITHIONECaball Sales, Inc.05e3fac4-c0ce-cbb9-e063-6294a90ac0362026-01-08WarningsExact identifier
application number: M032
Mens Rogaine 2% Salicylic Acid Anti-Dandruff Plus ConditionerSALICYLIC ACIDKenvue Brands LLC44906677-88a2-7c68-e063-6294a90a30172026-01-02WarningsExact identifier
application number: M032
Max OUTBENZALKONIUM CHLORIDEUnico475903d2-a0b0-5d29-e063-6394a90a528f2026-01-01WarningsExact identifier
application number: M032
Flakes Cedar Mint Anti DandruffPYRITHIONE ZINCCosco International, Inc.8575e7a0-4290-40a0-949c-317951b440b82026-01-01WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad7707-9d02-31a6-e053-2a95a90ae7ad2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Dandruff Defense Intensive Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ada541-f12b-76f2-e053-2a95a90a52862025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Lemon Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companye7903f3d-9c5a-f397-e053-2995a90a78952025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Dry Scalp Care with Almond and Coconut OilPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyed0bd699-c243-60f4-e053-2995a90a781f2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Shea ButterPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80a1580-38ba-3dae-e053-6394a90aff5d2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Ginger 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80a83cc-1174-3ec3-e053-6394a90ab0122025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Shea Butter Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf7ff4442-5d3f-034a-e053-6394a90a686d2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Clinical Dry Scalp Rescue KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company1a3ac96a-04ec-6865-e063-6394a90a9fb82025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Hydration DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80aee91-5643-ebbc-e053-6294a90aa5ab2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Cleanse DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf81e8a83-db95-8246-e053-6294a90a40a42025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Cleanse 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf81eb5d0-e392-0152-e053-6294a90a29072025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Hydration 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80e8a60-2b0f-dce2-e053-6394a90ab2752025-12-31WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2467167Nizoral Psoriasis 3 % Medicated ShampooPSN6ad7f931-5411-474b-a86e-b511811b7dc05
205023salicylic acid 3 % Medicated ShampooPSN6ad7f931-5411-474b-a86e-b511811b7dc05
2467167salicylic acid 30 MG/ML Medicated Shampoo [Nizoral Psoriasis]SBD6ad7f931-5411-474b-a86e-b511811b7dc05
205023salicylic acid 30 MG/ML Medicated ShampooSCD6ad7f931-5411-474b-a86e-b511811b7dc05
2467167Nizoral Psoriasis 3 % Medicated ShampooSY6ad7f931-5411-474b-a86e-b511811b7dc05
2467167Nizoral Psoriasis 30 MG/ML Medicated ShampooSY6ad7f931-5411-474b-a86e-b511811b7dc05
205023salicylic acid 3 % Medicated ShampooSY6ad7f931-5411-474b-a86e-b511811b7dc05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-202-64555050202641 BOTTLE in 1 CARTON (55505-202-64) / 325 mL in 1 BOTTLE1 bottle2020-12-010000-00-00NoNoCurrent