FDA.reportPublic FDA data

DermaSolve Medicated

Product NDC
84285-101
11-digit product format
842850101
Labeler code
84285
Product ID
84285-101_24fea3b2-1f0b-e289-e063-6394a90a5641
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
Fortitude Health, LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-21
Substance
SALICYLIC ACID
Active strength
3 g/100g
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
DermaSolve Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID3 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205023Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24fea3b2-1f0a-e289-e063-6394a90a5641Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84285-101-08DermaSolve Medicated226 g in 1 BOTTLELOTION/SHAMPOO2261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84285-101DERMASOLVE MEDICATED (SALICYLIC ACID) LOTION/SHAMPOO [FORTITUDE HEALTH, LLC]1Current NDC, 1 package rows20241023_24fea3b2-1f0a-e289-e063-6394a90a5641.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 18 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief SerumPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company402e2561-e309-46f2-e063-6394a90a4e582025-10-02WarningsExact identifier
application number: M032
J1002902 Jason Dandruff Relief 2in1 TreatmentPYRITHIONE ZINCThe Hain Celestial Group Inc8c631014-3832-78cb-e053-2995a90a8d222025-10-01WarningsExact identifier
application number: M032
iBeaLee 5% Minoxidil Hair Regrowth SolutionMINOXIDILShenzhen Earth Surface Trading Co., Ltd.40001edd-d98c-4e2a-e063-6394a90a99112025-09-30WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Complete Hydration 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company3f66839a-0d8f-e476-e063-6294a90a547c2025-09-22WarningsExact identifier
application number: M032
5% MINOXIDIL HAIR REGROWTH SERUM With BiotinMINOXIDILShenzhen Ctrip Technology Co., Ltd.1eae27bc-1b18-ae5d-e063-6394a90a46102025-09-12WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad107b-024b-828f-e053-2995a90aae362025-09-04WarningsExact identifier
application number: M032
Hermon Folliculitis Shampoo.SALICYLIC ACID 2%Beautivity LLC3c5f7caa-a4af-2574-e063-6394a90a75072025-08-14WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205023salicylic acid 3 % Medicated ShampooPSN24fea3b2-1f0a-e289-e063-6394a90a56411
205023salicylic acid 30 MG/ML Medicated ShampooSCD24fea3b2-1f0a-e289-e063-6394a90a56411
205023salicylic acid 3 % Medicated ShampooSY24fea3b2-1f0a-e289-e063-6394a90a56411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84285-101-0884285010108226 g in 1 BOTTLE (84285-101-08) 226 g2024-10-21NoNoCurrent