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 firm2026-09-09
excluded packagepackage55505-20255505-202-65DDiscontinued by firm2026-09-09

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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact identifier
application number: M032
apgwgzminoxidil5%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd596d0b43-5cb1-be25-e063-6394a90abbed2026-08-19WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC280391ce-ccd9-4b39-95a2-93e7fca84ccc2026-08-18WarningsExact identifier
application number: M032
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC3983b688-28ae-462e-8686-6cf2f2c1cca42026-08-18WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.SALICYLIC ACID 3%RoyceDerm LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact 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