FDA.reportPublic FDA data

Compound W

Product NDC
51142-595
Requested package NDC
51142-595-12
11-digit product format
511420595
Labeler code
51142
Product ID
51142-595_52ccbaf1-bf0c-4adc-e063-6294a90ac8cc
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic acid gel
Dosage form
GEL
Route
TOPICAL
Labeler
ASO LLC
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
Marketing end
2029-02-20
Substance
SALICYLIC ACID
Active strength
170 mg/g
NDC exclude flag
No
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51142-59551142-595-12IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

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
Compound W

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID170 mg/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
210140Internal RxNorm lookup
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
b55c7421-a8fe-8d4e-e053-2a95a90a7a6fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51142-595-122022-09-15C16284748780-1e4f33bdf-9f3b-d8a0-e053-dadaa90a6e4eCOMPOUND W WART REMOVER SALICYLIC ACID MAXIMUM STRENGTH FAST ACTING GEL + SHIELD
51142-595-122022-07-29C16284748780-1e4f33bdf-9f3b-d8a0-e053-dadaa90a6e4eCOMPOUND W WART REMOVER SALICYLIC ACID MAXIMUM STRENGTH FAST ACTING GEL + SHIELD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51142-595-12Compound W7 g in 1 TUBEGEL75
51142-595-12Compound W1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51142-595COMPOUND W (SALICYLIC ACID GEL) GEL [ASO LLC]4Current NDC, Legacy NDC, 2 package rows20231116_b55c7421-a8fe-8d4e-e053-2a95a90a7a6f.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 1 of 16 · 316 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dcsily Liquid Wart Corn RemoverLIQUID WART CORN REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.5b1bf2f7-422f-8713-e063-6394a90adee32026-09-10WarningsExact identifier
application number: M028
OJIOG WART REMOVER CreamSALICYLIC ACID 40% WART REMOVER CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1cff55-0478-62d2-e063-6394a90abfc72026-09-10WarningsExact identifier
application number: M028
Ronxiva WART REMOVERSALICYLIC ACID 40% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.5b181d86-6f28-890a-e063-6294a90a34392026-09-09WarningsExact identifier
application number: M028
TepidSun WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5a181d19-86e2-97b1-e063-6394a90a19f12026-09-08WarningsExact identifier
application number: M028
TRLYC WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.59b4d4a2-f7c5-a73a-e063-6294a90ae8c02026-09-08WarningsExact identifier
application number: M028
Aiilo WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58ad9307-a9f9-4de8-e063-6394a90adaa62026-09-08WarningsExact identifier
application number: M028
Aiilo WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58af5ac2-75a7-246d-e063-6394a90ae9662026-09-08WarningsExact identifier
application number: M028
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-09-08WarningsExact identifier
application number: M028
GPPEE WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5715c122-8ba8-6f1e-e063-6294a90a805f2026-09-08WarningsExact identifier
application number: M028
DVO WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57028c23-e012-9066-e063-6394a90a910b2026-09-08WarningsExact identifier
application number: M028
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.56e118b3-c27f-c14a-e063-6394a90ab75e2026-09-08WarningsExact identifier
application number: M028
GPPEE WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.568a84eb-c0f7-6ce6-e063-6294a90a15b42026-09-08WarningsExact identifier
application number: M028
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5652eb70-23f2-91cb-e063-6294a90a11962026-09-08WarningsExact identifier
application number: M028
Jorvinl WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.55c66a49-9d89-84a2-e063-6294a90a114e2026-09-08WarningsExact identifier
application number: M028
Youggle WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.54e97ada-b3fa-0411-e063-6294a90a6ecd2026-09-08WarningsExact identifier
application number: M028
OCSINL WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.54c206b9-758e-4baf-e063-6394a90afa992026-09-08WarningsExact identifier
application number: M028
DVO WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.53e389a6-722c-dc65-e063-6294a90ac7dc2026-09-08WarningsExact identifier
application number: M028
Flyleaf WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.53f1ca40-e909-e9df-e063-6294a90a97912026-09-08WarningsExact identifier
application number: M028
QKEKL WART REMOVERSALICYLIC ACID 45%Guangzhou Huixue Biotechnology Co., Ltd.5aeeafa6-4167-dcc3-e063-6294a90a26bb2026-09-07WarningsExact identifier
application number: M028
WOPRES WART REMOVERSALICYLIC ACID 45%Guangzhou Huixue Biotechnology Co., Ltd.5aef5afe-d3f3-4af8-e063-6394a90a28cb2026-09-07WarningsExact identifier
application number: M028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210140Compound W 17 % Topical GelPSNb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
312880salicylic acid 17 % Topical GelPSNb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
210140salicylic acid 0.17 MG/MG Topical Gel [Compound W brand of salicylic acid]SBDb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
312880salicylic acid 0.17 MG/MG Topical GelSCDb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
210140Compound W brand of salicylic acid 0.17 MG/MG Topical GelSYb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
210140Compound W brand of salicylic acid 17 % Topical GelSYb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
312880salicylic acid 17 % Topical GelSYb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51142-595-12511420595121 TUBE in 1 CARTON (51142-595-12) / 7 g in 1 TUBE1 tube2020-12-012029-02-20NoNoCurrent