FDA.reportPublic FDA data

Salicylic Acid

Product NDC
36800-376
11-digit product format
368000376
Labeler code
36800
Product ID
36800-376_5c5325b6-2833-2e36-e063-6294a90a409a
Type
HUMAN OTC DRUG
Nonproprietary name
Wart Remover Liquid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-06
Substance
SALICYLIC ACID
Active strength
.17 mg/9mL
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.17 mg/9mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-376-092023-01-31C16284748780-1f386c649-f4c7-0266-e053-dadaa90a7c1aTopcare Liquid Wart Remover
36800-376-092023-01-31C16284748780-1f386c649-f4c7-0266-e053-dadaa90a7c1aTopcare Liquid Wart Remover
36800-376-092023-01-31C16284748780-1f386c649-f4c7-0266-e053-dadaa90a7c1aTopcare Liquid Wart Remover

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-376-09Salicylic Acid9 mL in 1 BOTTLE, WITH APPLICATORLIQUID97

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-376SALICYLIC ACID (WART REMOVER LIQUID) LIQUID [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 1 package rows20241213_78beaf1b-14a2-45f9-ad0d-0d8953d316b3.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-376-09368000376099 mL in 1 BOTTLE, WITH APPLICATOR (36800-376-09) 9 ml2017-12-060000-00-00NoNoCurrent