FDA.reportPublic FDA data

Salicylic Acid

Product NDC
56104-017
11-digit product format
561040017
Labeler code
56104
Product ID
56104-017_476e735c-4f3a-b6c4-e063-6394a90a8c2b
Type
HUMAN OTC DRUG
Nonproprietary name
Wart Removers
Dosage form
PATCH
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
40 mg/181
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56104-017-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56104-017-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage56104-017-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage56104-017-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage56104-017-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage56104-017-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage56104-017-180efc9e666f02…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
Salicylic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID40 mg/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
ec588377-e672-4960-a3ca-2286f72ef5a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-017-18Salicylic Acid18 in 1 BOXPATCH1813

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID (WART REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID (WART REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7SALICYLIC ACID (WART REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SALICYLIC ACID (WART REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]1
VINYL ACETATEINACTIVE INGREDIENTL9MK238N77SALICYLIC ACID (WART REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]1

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
240559salicylic acid 40 % Medicated PatchPSNec588377-e672-4960-a3ca-2286f72ef5a513
240559salicylic acid 0.4 MG/MG Medicated PatchSCDec588377-e672-4960-a3ca-2286f72ef5a513
240559salicylic acid 40 % Medicated PatchSYec588377-e672-4960-a3ca-2286f72ef5a513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-017-185610400171818 PATCH in 1 BOX (56104-017-18) 18 patch2013-01-010000-00-00NoNoCurrent