FDA.reportPublic FDA data

Psoriasin

Product NDC
52389-752
11-digit product format
523890752
Labeler code
52389
Product ID
52389-752_53c43a2c-077a-71a9-e063-6394a90a5d38
Type
HUMAN OTC DRUG
Nonproprietary name
Coal Tar
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kobayashi Healthcare International, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-21
Substance
COAL TAR
Active strength
20 mg/g
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
Psoriasin
Brand name suffix
Deep Moisturizing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COAL TAR20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R533ESO2ECInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317080Internal RxNorm lookup
798505Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bb4a84f-dd80-cbbc-e053-2a95a90a0475Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-752-02PsoriasinDeep Moisturizing119 g in 1 TUBEOINTMENT1198
52389-752-42PsoriasinDeep Moisturizing119 g in 1 TUBEOINTMENT1198
52389-752-42PsoriasinDeep Moisturizing1 in 1 CARTONOINTMENT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-752PSORIASIN DEEP MOISTURIZING (COAL TAR) OINTMENT [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]7Current NDC, Legacy NDC, 3 package rows20241115_8bb4a84f-dd80-cbbc-e053-2a95a90a0475.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 17 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaZincPYRITHIONE ZINCWynnPharm Ince73010ae-291d-6adf-e053-2a95a90a8aea2025-11-14WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7bbd2559-4aba-9f18-e053-2991aa0a152e2025-11-13WarningsExact identifier
application number: M032
Divine Dandrene 1%ZINC PYRITHIONEDS Healthcare Group, Inc.ab605699-4090-45a3-882f-44379fe2a82e2025-11-11WarningsExact identifier
application number: M032
Divine Dandrene 2%ZINC PYRITHIONEDS Healthcare Group, Inc.54b0a610-dd15-4064-9feb-4d30b5e522ad2025-11-11WarningsExact identifier
application number: M032
Dandrene Anti-Dandruff ConditionerZINC PYRITHIONEDS Healthcare Group, Inc.aed49bfe-e016-46ac-a025-81b47cc081472025-11-11WarningsExact identifier
application number: M032
Minoxidil hair growth serumMINOXIDIL HAIR GROWTH SERUMJiashen International Trade Limited26cc22be-30f6-03da-e063-6394a90aafe72025-11-09WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.89f4ecc8-7a49-42cb-b85d-71c9299e67122025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Aqua BluePYRITHIONE ZINCJ. Strickland & Co.cdcf3cea-4a5d-4b8b-b47d-3163f9837d162025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff ControlPYRITHIONE ZINCJ. Strickland and Co.96b26da0-d0d7-77ed-e053-2995a90a7a782025-11-07WarningsExact identifier
application number: M032
Shailee Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd02a71ce4-baf5-4231-afd6-21ef0b22e9312025-11-05WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.8e9da3fd-701e-4354-bb00-ecd4dab48fa32025-11-03WarningsExact identifier
application number: M032
Denorex Severe Flakes Medicated Anti DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.41ad0d3a-0704-44c9-e063-6394a90ad40d2025-10-21WarningsExact identifier
application number: M032
Stay Minoxidil Hair Regrowth TreatmentMINOXIDIL 5%HALORIA INC.41b745d7-6947-ec24-e063-6294a90aa4672025-10-21WarningsExact identifier
application number: M032
DERMOSCRIBE SEBORRHEIC DERMATITISSULFUR, SALICYLIC ACID, HYDROCORTISONEDERMOSCRIBE PTY LTD2b6bf90b-5d42-4c08-afee-56e13122285e2025-10-17WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAYConopco, Inc. d/b/a Unilever414ab8ec-165c-21f8-e063-6294a90adc4f2025-10-16WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-INConopco, Inc. d/b/a Unilever414b7fd2-6a65-af39-e063-6394a90a00b82025-10-16WarningsExact identifier
application number: M032
Seacall Natural Cedarwood OilNATURAL CEDARWOOD OILGuangdong Quadrant Ecological Technology Co., Ltd.1f4ebe4d-6e93-378c-e063-6394a90aec952025-10-15WarningsExact identifier
application number: M032
RemedyDandruffShampooTreatmentACTIIV REMEDY DANDRUFF SHAMPOO TREATMENTNaturich Cosmetique Labs129fd043-6643-cc46-e063-6294a90a6eae2025-10-08WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company40464e2d-f738-33ec-e063-6394a90a02c22025-10-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company4046c345-e1ac-0ecc-e063-6294a90a59fa2025-10-03WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317080coal tar 2 % Topical OintmentPSN8bb4a84f-dd80-cbbc-e053-2a95a90a04758
798505Psoriasin 2 % Topical OintmentPSN8bb4a84f-dd80-cbbc-e053-2a95a90a04758
798505coal tar 0.02 MG/MG Topical Ointment [Psoriasin]SBD8bb4a84f-dd80-cbbc-e053-2a95a90a04758
317080coal tar 0.02 MG/MG Topical OintmentSCD8bb4a84f-dd80-cbbc-e053-2a95a90a04758
317080crude coal tar 2 % (coal tar solution 10 % ) Topical OintmentSY8bb4a84f-dd80-cbbc-e053-2a95a90a04758
798505Psoriasin (crude coal tar 2 % ) Topical OintmentSY8bb4a84f-dd80-cbbc-e053-2a95a90a04758
798505Psoriasin 2 % Topical OintmentSY8bb4a84f-dd80-cbbc-e053-2a95a90a04758

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-752-0252389075202119 g in 1 TUBE (52389-752-02) 119 g2019-06-210000-00-00NoNoCurrent
52389-752-42523890752421 TUBE in 1 CARTON (52389-752-42) / 119 g in 1 TUBE1 tube2019-06-210000-00-00NoNoCurrent