FDA.reportPublic FDA data

Dermabon Multi Symptom Psoriasis Control

Product NDC
49758-001
11-digit product format
497580001
Labeler code
49758
Product ID
49758-001_38dece0a-453d-3502-e063-6394a90a99b0
Type
HUMAN OTC DRUG
Nonproprietary name
COAL TAR
Dosage form
SOAP
Route
TOPICAL
Labeler
Dermabon de Chihuahua, S.A. de C.V.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Marketing end
2028-12-31
Substance
COAL TAR
Active strength
21.3 mg/g
NDC exclude flag
No
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
Dermabon Multi Symptom Psoriasis Control

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COAL TAR21.3 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038967Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5b739ba-e332-41f6-9343-6ad5cc981344Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49758-001-01Dermabon Multi Symptom Psoriasis Control1 in 1 CARTONSOAP17
49758-001-01Dermabon Multi Symptom Psoriasis Control90 g in 1 BAGSOAP907
49758-001-03Dermabon Multi Symptom Psoriasis Control90 g in 1 BAGSOAP907
49758-001-03Dermabon Multi Symptom Psoriasis Control3 in 1 CARTONSOAP37
49758-001-06Dermabon Multi Symptom Psoriasis Control6 in 1 CARTONSOAP67
49758-001-06Dermabon Multi Symptom Psoriasis Control90 g in 1 BAGSOAP907

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
1038967coal tar 2.13 % Medicated Bar SoapPSNd5b739ba-e332-41f6-9343-6ad5cc9813447
1038967coal tar 0.0213 MG/MG Medicated Bar SoapSCDd5b739ba-e332-41f6-9343-6ad5cc9813447
1038967coal Tar 2.13 % Medicated Bar SoapSYd5b739ba-e332-41f6-9343-6ad5cc9813447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49758-001-01497580001011 BAG in 1 CARTON (49758-001-01) / 90 g in 1 BAG1 bag2022-07-012028-12-31NoNoHistorical
49758-001-03497580001033 BAG in 1 CARTON (49758-001-03) / 90 g in 1 BAG3 bag2022-07-012028-12-31NoNoHistorical
49758-001-06497580001066 BAG in 1 CARTON (49758-001-06) / 90 g in 1 BAG6 bag2022-07-012028-12-31NoNoHistorical