FDA.reportPublic FDA data

Wart Remover Gel

Product NDC
56104-237
Requested package NDC
56104-237-07
11-digit product format
561040237
Labeler code
56104
Product ID
56104-237_32d28d8e-c7ac-2e09-e063-6294a90aee0a
Type
HUMAN OTC DRUG
Nonproprietary name
Wart Remover Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Substance
SALICYLIC ACID
Active strength
.17 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
Wart Remover Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.17 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312880Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db4ba7ac-a58b-42d5-9181-da70309f1791Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-237-07Wart Remover Gel7 g in 1 TUBEGEL711

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941WART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
HYPOPHOSPHOROUS ACIDINACTIVE INGREDIENT8B1RL9B4ZJWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2
PYROXYLININACTIVE INGREDIENTKYR8BR2X6OWART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-237WART REMOVER GEL GEL [PREMIER BRANDS OF AMERICA INC.]11Current NDC, Legacy NDC, 1 package rows20250417_db4ba7ac-a58b-42d5-9181-da70309f1791.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 6 of 16 · 305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerraCalm Wart Removal GelSALICYLIC ACID 5% WART REMOVAL GELWenzhou Yuyuan Pharmaceutical Co., Ltd.550a761b-dac9-d4cf-e063-6294a90a346b2026-06-24WarningsExact identifier
application number: M028
Wart RemoverSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.54ec6464-8a9b-5064-e063-6394a90a0b412026-06-23WarningsExact identifier
application number: M028
GAVNZ WART REMOVER patchesSALICYLIC ACID 40% WART REMOVER PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.54839f38-dd77-eb80-e063-6294a90a2eed2026-06-18WarningsExact identifier
application number: M028
Musizlee WART REMOVERSALICYLIC ACID 1% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.545a9483-dc13-3675-e063-6294a90aebde2026-06-16WarningsExact identifier
application number: M028
ASTEROSE WART REMOVERSALICYLIC ACID 1% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.545611a2-0c97-de73-e063-6294a90a11ff2026-06-15WarningsExact identifier
application number: M028
Medyi Liquid WART CORN REMOVERSALICYLIC ACID 17% LIQUID WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD51817785-f5c1-0cee-e063-6394a90aec102026-06-14WarningsExact identifier
application number: M028
HEALMUSZ FAST NATURAL WART REMOVALSALICYLIC ACID 17% FAST NATURAL WART REMOVALJiangxi Yudexi Pharmaceutical Co., LTD4a35d177-1530-43f6-e063-6394a90adbe72026-06-14WarningsExact identifier
application number: M028
HEALMUSZ SKIN TAG REMOVERSALICYLIC ACID 17% SKIN TAG REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a32de1b-947c-8b6e-e063-6294a90aa1602026-06-14WarningsExact identifier
application number: M028
HEALMUSZ WART REMOVERSALICYLIC ACID 5% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a334101-b75a-15c3-e063-6294a90ac7a62026-06-14WarningsExact identifier
application number: M028
HEALMUSZ WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a35205d-9a1f-da6a-e063-6394a90a9cb32026-06-14WarningsExact identifier
application number: M028
HEALMUSZ WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a34122b-0bb3-e600-e063-6394a90ac66d2026-06-14WarningsExact identifier
application number: M028
PUVIDA Liquid WART CORN REMOVERSALICYLIC ACID 17% LIQUID WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a48bccd-9430-d282-e063-6294a90a74c72026-06-14WarningsExact identifier
application number: M028
PUVIDA WART REMOVAL SystemSALICYLIC ACID 17% WART REMOVAL SYSTEMJiangxi Yudexi Pharmaceutical Co., LTD4a488766-b469-1e46-e063-6294a90a70782026-06-14WarningsExact identifier
application number: M028
Bighero GENITAL WART REMOVERSALICYLIC ACID 17% GENITAL WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496e178e-0172-21e6-e063-6394a90ae1ce2026-06-12WarningsExact identifier
application number: M028
Bighero Liquid Wart Corn Callus RemoverSALICYLIC ACID 17% LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496ef896-3c20-eec7-e063-6294a90a2ead2026-06-12WarningsExact identifier
application number: M028
BITANK Liquid WART CORN CALLUS REMOVERBITANK LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496f7a1e-05b4-d434-e063-6394a90afe542026-06-12WarningsExact identifier
application number: M028
Dhizhayo WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496ff16d-a18b-c660-e063-6294a90ab8f42026-06-12WarningsExact identifier
application number: M028
CODECURE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a462f8c-e49f-4d01-e063-6394a90a45442026-06-12WarningsExact identifier
application number: M028
HEALSURE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a466b8e-5684-91e8-e063-6394a90a67132026-06-12WarningsExact identifier
application number: M028
HEALSURE WART MOLES REMOVERSALICYLIC ACID 17% WART MOLES REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4693f9-37d5-b8da-e063-6394a90a4ef32026-06-12WarningsExact identifier
application number: M028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312880salicylic acid 17 % Topical GelPSNdb4ba7ac-a58b-42d5-9181-da70309f179111
312880salicylic acid 0.17 MG/MG Topical GelSCDdb4ba7ac-a58b-42d5-9181-da70309f179111
312880salicylic acid 17 % Topical GelSYdb4ba7ac-a58b-42d5-9181-da70309f179111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-237-07561040237077 g in 1 TUBE (56104-237-07) 7 g2013-01-010000-00-00NoNoCurrent