FDA.reportPublic FDA data

Salicylic Acid

Product NDC
83324-231
11-digit product format
833240231
Labeler code
83324
Product ID
83324-231_53d7a3fc-10e5-c5f5-e063-6294a90ace86
Type
HUMAN OTC DRUG
Nonproprietary name
Medicated Plantar Wart Remover
Dosage form
PATCH
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-29
Substance
SALICYLIC ACID
Active strength
400 mg/g
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
Salicylic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID400 mg/g

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
240559Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
342a6b6c-3af7-d4fc-e063-6294a90a142cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-231-24Salicylic Acid24 in 1 BOXPATCH244
83324-231-24Salicylic Acid1 g in 1 PATCHPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-231SALICYLIC ACID (MEDICATED PLANTAR WART REMOVER) PATCH [CHAIN DRUG MARKETING ASSOCIATION]1Current NDC, 2 package rows20250504_342a6b6c-3af7-d4fc-e063-6294a90a142c.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 16 of 16 · 305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulensy Corn Callus and Wart RemoverCORN CALLUS AND WART REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.0f3353ef-e105-7bd4-e063-6394a90a25622024-01-18WarningsExact identifier
application number: M028
WARTRIN Wart RemoverSALICYLIC ACIDBALBOA COMPANIES LLC62c99f48-3dc1-4b41-8bc4-e93e2decadd92023-11-11WarningsExact identifier
application number: M028
UFORIC Wart RemoverSALICYLIC ACIDUFORIC HEALTH LLC0d06cac6-5296-4d8a-b59e-966baac6be5f2023-11-06WarningsExact identifier
application number: M028
WARTOVIR Wart RemoverSALICYLIC ACIDBALBOA COMPANIES LLC2dbf5b40-d759-4c37-8dfe-3b65a7e6dbb62023-11-06WarningsExact identifier
application number: M028
VerruStat Wart RemoverSALICYLIC ACIDClinical Therapeutic Solutions16607d6e-6a5f-4b03-b38c-3610aef9b1652023-11-05WarningsExact identifier
application number: M028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240559salicylic acid 40 % Medicated PatchPSN342a6b6c-3af7-d4fc-e063-6294a90a142c4
240559salicylic acid 0.4 MG/MG Medicated PatchSCD342a6b6c-3af7-d4fc-e063-6294a90a142c4
240559salicylic acid 40 % Medicated PatchSY342a6b6c-3af7-d4fc-e063-6294a90a142c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-231-248332402312424 PATCH in 1 BOX (83324-231-24) / 1 g in 1 PATCH24 patch2025-04-29NoNoCurrent