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 22 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders 2in1 Men Vanilla and AmberPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cf441e0-3ddd-0f9e-e063-6394a90a092c2025-01-30WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Full and ThickPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3f0664-a9e7-6b63-e053-2991aa0a4b0a2025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cdb1e94-3923-84f7-e063-6394a90a07d52025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp ReliefPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc7724c-a1f1-a42d-e063-6394a90a83cf2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Swagger Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3cca83-f99e-2c30-e053-2991aa0a4c9d2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2ccaceed-9928-ef05-e063-6394a90a65112025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Soothing HydrationPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003d1723-1fd9-ef2b-e063-6294a90aafda2025-01-28WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c7630ab-b7fa-462c-e063-6394a90a30bb2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c762c86-ba7a-1976-e063-6394a90a49f22025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c764242-df65-7383-e063-6394a90a34b02025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c767d79-6ffe-ebaa-e063-6394a90a39d12025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c77edae-be2b-3a37-e063-6294a90a001d2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c77e4b6-5a65-c7ea-e063-6394a90a6abb2025-01-24WarningsExact identifier
application number: M032
Zincon Medicated Anti-DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.2c26bd1e-35d4-f1a2-e063-6294a90af5762025-01-23WarningsExact identifier
application number: M032
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c6289a3-2f09-c094-e063-6394a90a81f92025-01-23WarningsExact identifier
application number: M032
Tuymec Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOGuangzhou Zanming Trading Co., Ltd.2c62d04e-dcb6-a33e-e063-6394a90a2e8e2025-01-23WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARChain Drug Marketing Association, Inc.2bea5414-c7bc-d010-e063-6294a90aa1382025-01-17WarningsExact identifier
application number: M032
Meijer Medicated Selenium Sulfide Anti-DandruffSELENIUM SULFIDEMeijer Distribution, Inc41b563c6-5df6-4ead-bddf-a69a07970ea02025-01-14WarningsExact identifier
application number: M032
D-COL Personal Hygiene Convenience kitPYRITHIONE ZINC AND CHLOROXYLENOLD-COL Inc273fcc6f-9c54-42b0-aa0c-9051457b13412025-01-14WarningsExact identifier
application number: M032
Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.f8767db7-e208-4ccc-85f7-789e281c7f262025-01-10WarningsExact 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