FDA.reportPublic FDA data

Bighero GENITAL WART REMOVER

Product NDC
85248-014
11-digit product format
852480014
Labeler code
85248
Product ID
85248-014_540ac8c5-4021-dba0-e063-6394a90ade33
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic acid 17% GENITAL WART REMOVER
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-28
Substance
SALICYLIC ACID
Active strength
17 g/100g
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
Bighero GENITAL WART REMOVER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID17 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
496e178e-0172-21e6-e063-6394a90ae1ceAvailable 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
85248-014-01Bighero GENITAL WART REMOVER20 g in 1 TUBECREAM201
85248-014-02Bighero GENITAL WART REMOVER20 g in 1 TUBECREAM201
85248-014-02Bighero GENITAL WART REMOVER2 in 1 BOXCREAM21

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 startSampleExclude flagStatus
85248-014-018524800140120 g in 1 TUBE (85248-014-01) 20 g2026-01-28NoNoCurrent
85248-014-02852480014022 TUBE in 1 BOX (85248-014-02) / 20 g in 1 TUBE2 tube2026-01-28NoNoCurrent