FDA.reportPublic FDA data

Compound W

Product NDC
63029-595
11-digit product format
630290595
Labeler code
63029
Product ID
63029-595_42137a7e-8688-45d2-929e-5dc73723e5d7
Type
HUMAN OTC DRUG
Nonproprietary name
salicylic acid
Dosage form
GEL
Route
TOPICAL
Labeler
Medtech Products Inc.
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-15
Substance
SALICYLIC ACID
Active strength
170 mg/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
Compound W
Listing expiration
2027-12-31

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
0b25a21a-d843-49f7-a2cc-11958fd66ac4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-595-12Compound W7 g in 1 TUBEGEL711
63029-595-12Compound W1 in 1 CARTONGEL111
63029-595-14Compound W1 in 1 CARTONGEL111
63029-595-14Compound W7 g in 1 BOTTLEGEL711
63029-595-25Compound W1 in 1 CARTONGEL111
63029-595-25Compound W7 g in 1 TUBEGEL711
63029-595-30Compound W1 in 1 CARTONGEL111
63029-595-30Compound W7 g in 1 TUBEGEL711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-595COMPOUND W (SALICYLIC ACID) GEL [MEDTECH PRODUCTS INC.]10Current NDC, Legacy NDC, 8 package rows20240606_0b25a21a-d843-49f7-a2cc-11958fd66ac4.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
210140Compound W 17 % Topical GelPSN0b25a21a-d843-49f7-a2cc-11958fd66ac411
312880salicylic acid 17 % Topical GelPSN0b25a21a-d843-49f7-a2cc-11958fd66ac411
210140salicylic acid 0.17 MG/MG Topical Gel [Compound W brand of salicylic acid]SBD0b25a21a-d843-49f7-a2cc-11958fd66ac411
312880salicylic acid 0.17 MG/MG Topical GelSCD0b25a21a-d843-49f7-a2cc-11958fd66ac411
210140Compound W brand of salicylic acid 0.17 MG/MG Topical GelSY0b25a21a-d843-49f7-a2cc-11958fd66ac411
210140Compound W brand of salicylic acid 17 % Topical GelSY0b25a21a-d843-49f7-a2cc-11958fd66ac411
312880salicylic acid 17 % Topical GelSY0b25a21a-d843-49f7-a2cc-11958fd66ac411
210140Compound W 17 % Topical GelPSNe8938dc4-25a7-4edb-9906-784b78a479901
312880salicylic acid 17 % Topical GelPSNe8938dc4-25a7-4edb-9906-784b78a479901
210140salicylic acid 0.17 MG/MG Topical Gel [Compound W brand of salicylic acid]SBDe8938dc4-25a7-4edb-9906-784b78a479901
312880salicylic acid 0.17 MG/MG Topical GelSCDe8938dc4-25a7-4edb-9906-784b78a479901
210140Compound W brand of salicylic acid 0.17 MG/MG Topical GelSYe8938dc4-25a7-4edb-9906-784b78a479901
210140Compound W brand of salicylic acid 17 % Topical GelSYe8938dc4-25a7-4edb-9906-784b78a479901
312880salicylic acid 17 % Topical GelSYe8938dc4-25a7-4edb-9906-784b78a479901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-595-12630290595121 TUBE in 1 CARTON (63029-595-12) / 7 g in 1 TUBE1 tube2014-03-150000-00-00NoNoCurrent
63029-595-14630290595141 BOTTLE in 1 CARTON (63029-595-14) / 7 g in 1 BOTTLE1 bottle2014-03-150000-00-00NoNoCurrent
63029-595-25630290595251 TUBE in 1 CARTON (63029-595-25) / 7 g in 1 TUBE1 tube2014-03-150000-00-00NoNoCurrent
63029-595-30630290595301 TUBE in 1 CARTON (63029-595-30) / 7 g in 1 TUBE1 tube2024-01-01NoNoCurrent