FDA.reportPublic FDA data

DERMOSCRIBE SEBORRHEIC DERMATITIS

Product NDC
69683-202
11-digit product format
696830202
Labeler code
69683
Product ID
69683-202_4161aee0-5f36-1739-e063-6294a90a5bdf
Type
HUMAN OTC DRUG
Nonproprietary name
SULFUR, SALICYLIC ACID, HYDROCORTISONE
Dosage form
CREAM
Route
TOPICAL
Labeler
DERMOSCRIBE PTY LTD
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-23
Substance
SULFUR; SALICYLIC ACID; HYDROCORTISONE
Active strength
3; 3; 1 g/100g; g/100g; g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
DERMOSCRIBE SEBORRHEIC DERMATITIS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR3 g/100g
SALICYLIC ACID3 g/100g
HYDROCORTISONE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup
O414PZ4LPZInternal UNII lookup
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738574Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b6bf90b-5d42-4c08-afee-56e13122285eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69683-202-11DERMOSCRIBE SEBORRHEIC DERMATITIS60 g in 1 BOTTLECREAM609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69683-202DERMOSCRIBE SEBORRHEIC DERMATITIS (SULFUR, SALICYLIC ACID, HYDROCORTISONE) CREAM [DERMOSCRIBE PTY LTD]8Current NDC, Legacy NDC, 1 package rows20241109_2b6bf90b-5d42-4c08-afee-56e13122285e.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 20 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Structure of Skin Soothing Anti-DandruffPYRITHIONE ZINCSTRUCTURE OF SKIN LLC3311fa83-a06b-b379-e063-6394a90ae2692025-04-18WarningsExact identifier
application number: M032
LILIVERA Hair Regrowth KitMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.330602da-ec17-5a35-e063-6394a90a741b2025-04-17WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for normal hairPYRITHIONE ZINCRejoice International Inc.b90e574c-933c-4f86-aadc-567ffbe6ea042025-04-09WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for sensitive hairPYRITHIONE ZINCRejoice International Inc.979394c2-5681-44c8-a43c-bf3a392bd0c12025-04-09WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.31ee4645-0f64-f7a0-e063-6394a90a17362025-04-04WarningsExact identifier
application number: M032
LEAHUE MADHUCASALICYLIC ACIDBio-interchange Co.81470dfe-f063-9d16-e053-2a91aa0a18292025-04-04WarningsExact identifier
application number: M032
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDNexgel,Inc.31ce20a2-95ae-e424-e063-6394a90af18a2025-04-01WarningsExact identifier
application number: M032
Kenkoderm PsoriasisSALICYLIC ACIDNexgel,Inc.31cf90e5-0f21-903d-e063-6394a90a075d2025-04-01WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31af9365-e1a3-7203-e063-6294a90a8ade2025-03-31WarningsExact identifier
application number: M032
Listarfe Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOOGuangzhou Zanming Trading Co., Ltd.3163eee0-379f-1f88-e063-6294a90a58ce2025-03-28WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD31392f0f-a6c4-1cfb-e063-6294a90a4d362025-03-26WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD313716f7-6dd2-e1c5-e063-6394a90a9de32025-03-25WarningsExact identifier
application number: M032
CeraVe Anti Dandruff HydratingPYRITHIONE ZINCL'Oreal USA Products Inc422e743b-fd77-40ed-8c5d-7f05112a447f2025-03-24WarningsExact identifier
application number: M032
Scalp RevivalSALICYLIC ACID 3%Beccair, LLC0a77e90e-a33a-43f3-80a0-a16a6902a7352025-03-21WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDChattem, Inc.e8479bbc-5f49-41f2-851e-a935435166392025-03-19WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINCRejoice International Corp.308554c2-938b-f0b5-e063-6394a90a5bfa2025-03-17WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINCRejoice International Corp.3086d31e-54ef-9c0f-e063-6394a90abdff2025-03-17WarningsExact identifier
application number: M032
SA Scalp TherapySA SCALPMilbar Laboratories304db1ab-acd7-43d5-e063-6294a90aeec22025-03-14WarningsExact identifier
application number: M032
Neutrogena Scalp Therapy Anti-Dandruff Itchy ScalpSALICYLIC ACIDKenvue Brands LLCca4c0d63-50b3-169f-e053-2a95a90acbcd2025-03-10WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738574hydrocortisone 1 % / salicylic acid 3 % / sulfur 3 % Topical CreamPSN2b6bf90b-5d42-4c08-afee-56e13122285e9
1738574hydrocortisone 10 MG/ML / salicylic acid 30 MG/ML / sulfur 30 MG/ML Topical CreamSCD2b6bf90b-5d42-4c08-afee-56e13122285e9
1738574hydrocortisone 1 % / salicylic acid 3 % / sulfur 3 % Topical CreamSY2b6bf90b-5d42-4c08-afee-56e13122285e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69683-202-116968302021160 g in 1 BOTTLE (69683-202-11) 60 g2015-03-230000-00-00NoNoCurrent