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 20 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Koi Beauty 5% Minoxidil Hair Growth Serum5% MINOXIDIL HAIR GROWTH SERUMBeijing Sea Heart International Science And Technology Co.,Ltd.358dfbcd-6152-2842-e063-6394a90a2ab42025-05-20WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
application number: M032
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

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