FDA.reportPublic FDA data

Salicylic acid

Product NDC
36800-377
11-digit product format
368000377
Labeler code
36800
Product ID
36800-377_487592eb-cb0c-acf9-e063-6394a90a2ea1
Type
HUMAN OTC DRUG
Nonproprietary name
Wart Remover
Dosage form
PLASTER
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-06
Substance
SALICYLIC ACID
Active strength
.4 g/181
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 ACID.4 g/181

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
a373a743-daa1-4975-b8f5-5fc327f9d24aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-377-14Salicylic acid18 in 1 BOXPLASTER1810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-377SALICYLIC ACID (WART REMOVER) PLASTER [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 1 package rows20241215_a373a743-daa1-4975-b8f5-5fc327f9d24a.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 PatchPSNa373a743-daa1-4975-b8f5-5fc327f9d24a10
240559salicylic acid 0.4 MG/MG Medicated PatchSCDa373a743-daa1-4975-b8f5-5fc327f9d24a10
240559salicylic acid 40 % Medicated PatchSYa373a743-daa1-4975-b8f5-5fc327f9d24a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-377-143680003771418 PLASTER in 1 BOX (36800-377-14) 18 plaster2017-12-060000-00-00NoNoCurrent