FDA.reportPublic FDA data

WartStick Plantar

Product NDC
10107-251
11-digit product format
101070251
Labeler code
10107
Product ID
10107-251_23760d3b-ace6-0c10-e063-6394a90a77b2
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
STICK
Route
TOPICAL
Labeler
Balassa Laboratories Inc.
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
Substance
SALICYLIC ACID
Active strength
.4 g/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
WartStick Plantar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.4 g/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251407Internal RxNorm lookup
2043252Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfe2aa35-d780-4ae8-b230-019ec2e1a5c7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10107-251-022023-04-05C16284748780-1f386c64a-10ac-0266-e053-dadaa90a7c1aWartStick Plantar Wart Remover
10107-251-022023-01-30C16284748780-1f386c64a-10ac-0266-e053-dadaa90a7c1aWartStick Plantar Wart Remover

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10107-251-01WartStick Plantar9.6 g in 1 TUBESTICK9.65
10107-251-02WartStick Plantar1 in 1 CARTONSTICK15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10107-251WARTSTICK PLANTAR (SALICYLIC ACID) STICK [BALASSA LABORATORIES INC.]5Current NDC, Legacy NDC, 2 package rows20241004_dfe2aa35-d780-4ae8-b230-019ec2e1a5c7.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
251407salicylic acid 40 % Topical OintmentPSNdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
2043252WartSTICK 40 % Topical OintmentPSNdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
2043252salicylic acid 0.4 MG/MG Topical Ointment [Wartstick]SBDdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
251407salicylic acid 0.4 MG/MG Topical OintmentSCDdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
251407salicylic acid 40 % Topical OintmentSYdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
251407salicylic acid 40 % Topical StickSYdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
2043252Wartstick 0.4 MG/MG Topical OintmentSYdfe2aa35-d780-4ae8-b230-019ec2e1a5c75
2043252Wartstick 40 % Topical OintmentSYdfe2aa35-d780-4ae8-b230-019ec2e1a5c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10107-251-01101070251019.6 g in 1 TUBE9.6 gHistorical
10107-251-02101070251021 TUBE in 1 CARTON (10107-251-02) / 9.6 g in 1 TUBE (10107-251-01) 1 tube2020-06-010000-00-00NoNoCurrent