FDA.reportPublic FDA data

Salicylic Acid

Product NDC
68016-632
Requested package NDC
68016-632-00
11-digit product format
680160632
Labeler code
68016
Product ID
68016-632_c78ddd70-f29a-b5c3-e053-2995a90ae1ff
Type
HUMAN OTC DRUG
Nonproprietary name
Wart Remover Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
part358B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-20
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
0 g/7g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68016-63268016-632-00DDiscontinued by firm2026-10-15

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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-63268016-632-00DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-63268016-632-00DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941SALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
HYPOPHOSPHOROUS ACIDINACTIVE INGREDIENT8B1RL9B4ZJSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2
PYROXYLININACTIVE INGREDIENTKYR8BR2X6OSALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-632SALICYLIC ACID (WART REMOVER GEL) GEL [CHAIN DRUG CONSORTIUM, LLC]9Legacy NDC20241213_c8dd473b-9683-471f-b60d-349f12b1c1e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-632-00680160632007 g in 1 TUBE (68016-632-00) 7 g2011-10-200000-00-00NoNoCurrent