FDA.reportPublic FDA data

Denorex Severe Itch

Product NDC
62673-175
11-digit product format
626730175
Labeler code
62673
Product ID
62673-175_213cb08a-41af-72f5-e063-6294a90a41f2
Type
HUMAN OTC DRUG
Nonproprietary name
Coal Tar
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Neoteric Cosmetics, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-13
Substance
COAL TAR
Active strength
.018 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Denorex Severe Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COAL TAR.018 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
213ccbc4-2f52-58b6-e063-6294a90ae248Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62673-175-10Denorex Severe Itch296 mL in 1 BOTTLESHAMPOO2961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62673-175DENOREX SEVERE ITCH (COAL TAR) SHAMPOO [NEOTERIC COSMETICS, INC.]1Current NDC, 1 package rows20250523_213ccbc4-2f52-58b6-e063-6294a90ae248.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62673-175-1062673017510296 mL in 1 BOTTLE (62673-175-10) 296 ml2017-12-13NoNoCurrent