FDA.reportPublic FDA data

Salicylic Acid

Product NDC
63868-042
11-digit product format
638680042
Labeler code
63868
Product ID
63868-042_53d7f810-f474-2c21-e063-6294a90a63a2
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
2017-12-18
Marketing end
2027-06-30
Substance
SALICYLIC ACID
Active strength
40 mg/241
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID40 mg/241

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
ae38c7b0-d5c8-4f1f-ab4d-8e8ea5a095c1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-042-24Salicylic Acid24 in 1 BOXPATCH246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-042SALICYLIC ACID (MEDICATED PLANTAR WART REMOVER) PATCH [CHAIN DRUG MARKETING ASSOCIATION]6Current NDC, Legacy NDC, 1 package rows20241213_ae38c7b0-d5c8-4f1f-ab4d-8e8ea5a095c1.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 PatchPSNae38c7b0-d5c8-4f1f-ab4d-8e8ea5a095c16
240559salicylic acid 0.4 MG/MG Medicated PatchSCDae38c7b0-d5c8-4f1f-ab4d-8e8ea5a095c16
240559salicylic acid 40 % Medicated PatchSYae38c7b0-d5c8-4f1f-ab4d-8e8ea5a095c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-042-246386800422424 PATCH in 1 BOX (63868-042-24) 24 patch2017-12-182027-06-30NoNoCurrent