Salicylic acid

Product NDC
56104-244
11-digit product format
561040244
Labeler code
56104
Product ID
56104-244_e192e81a-b7fa-3461-e053-2995a90a7e2c
Type
HUMAN OTC DRUG
Nonproprietary name
Callus Removers
Dosage form
PATCH
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part358F
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-06-16
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
40 mg/41
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct56104-244DDiscontinued by firm2026-10-12
excluded packagepackage56104-24456104-244-01DDiscontinued by firm2026-10-12

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage56104-244-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56104-244-01f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-244SALICYLIC ACID (CALLUS REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]4Legacy NDC20241016_e192e81a-b7f9-3461-e053-2995a90a7e2c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-244-01561040244014 PATCH in 1 PACKAGE (56104-244-01) 4 patch2022-06-160000-00-00NoNoCurrent