FDA.reportPublic FDA data

Salicylic acid

Product NDC
56104-013
11-digit product format
561040013
Labeler code
56104
Product ID
56104-013_521e0a33-ba36-1799-e063-6394a90a5363
Type
HUMAN OTC DRUG
Nonproprietary name
Callus Removers
Dosage form
PATCH
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M030
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Marketing end
2027-06-30
Substance
SALICYLIC ACID
Active strength
40 mg/41
NDC exclude flag
No
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
Salicylic acid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID40 mg/41

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
0b637f58-5604-454d-99ba-24115113ac3dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-013-04Salicylic acid4 in 1 PACKAGEPATCH412

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-013SALICYLIC ACID (CALLUS REMOVERS) PATCH [PREMIER BRANDS OF AMERICA INC.]9Current NDC, Legacy NDC, 1 package rows20241013_0b637f58-5604-454d-99ba-24115113ac3d.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 2 of 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidCORN AND CALLUS REMOVER KITWal-Mart Stores, Inc.259fcbbd-08a2-cfcb-e063-6394a90ae7d12026-02-05WarningsExact identifier
application number: M030
Extra Thick Callus RemoversEXTRA THICK CALLUS REMOVERS WITH SALICYLIC ACIDWal-Mart Stores, Inc.83f3b428-e914-419b-8fa3-5444647a70612026-01-30WarningsExact identifier
application number: M030
Mqupin Liquid Wart Corn RemoverLIQUID WART CORN REMOVERZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09789de2-4e81-a6ed-e063-6394a90af5e02026-01-28WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CORN REMOVERSWal-Mart Stores Inc80c4907d-d4ea-42b0-e053-2a91aa0a173c2026-01-21WarningsExact identifier
application number: M030
Salicylic AcidCORN REMOVERSWalgreen Company249ba77f-fba4-41b4-83df-3f46fb94835a2026-01-20WarningsExact identifier
application number: M030
Salicylic AcidEXTRA THICK CALLUS REMOVERSWalgreen Companyfa2e95b5-fe90-4406-b981-05bca62fd25c2026-01-20WarningsExact identifier
application number: M030
Salicylic AcidCLEAR MEDICATED CORN REMOVERSWalgreens Companyf691fbf6-5e74-bac8-e053-2a95a90a67142026-01-20WarningsExact identifier
application number: M030
Salicylic AcidULTRA THIN CORN REMOVERSWalgreens Company822c6cbe-15a7-4183-b28b-f00a1d2c85242026-01-20WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSVALU MERCHANDISERS, CO468fd593-8b40-41b2-b419-d6550ed625412026-01-15WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSVALU MERCHANDISERS, COee15daa4-3325-4b16-8f84-ac7d39fa0aec2026-01-15WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKVALU MERCHANDISERS, COdd3c2727-e250-4a35-9256-856a775b948b2026-01-15WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKHEB51acb7ae-0217-4f35-853b-bdbea858482d2026-01-15WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSHEB553ff475-641d-4cc0-ab32-69cebec709ba2026-01-15WarningsExact identifier
application number: M030
Clear Corn Remover StripsSALICYLIC ACIDMEIJER DISTRIBUTION, INC.f83601c0-86b8-90fa-e053-6294a90af8322026-01-15WarningsExact identifier
application number: M030
Medicated Corn RemoversSALICYLIC ACIDMeijer Distribution Inc039da93c-5351-36f3-e063-6294a90aacb42026-01-15WarningsExact identifier
application number: M030
Salicylic AcidCLEAR MEDICATED CORN REMOVERSPremier Brands of America Inc.f5626988-a23d-44ea-e053-2a95a90a6bd02026-01-15WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKTopco Associates LLC397cbf46-a4d5-4fc4-a04e-ef947b638b472026-01-15WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSTopco Associates LLC7e94a826-4f6d-451a-b599-70f337aa287c2026-01-15WarningsExact identifier
application number: M030
Salicylic AcidCLEAR MEDICATED CORN REMOVERSCVS Pharmacyf55fd921-8b79-48e5-e053-2995a90acc782026-01-08WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSAmerisourceBergen Drug Corporationf407f14a-7c5c-481d-b1d1-1ea94b3a30292026-01-02WarningsExact identifier
application number: M030

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240559salicylic acid 40 % Medicated PatchPSN0b637f58-5604-454d-99ba-24115113ac3d12
240559salicylic acid 0.4 MG/MG Medicated PatchSCD0b637f58-5604-454d-99ba-24115113ac3d12
240559salicylic acid 40 % Medicated PatchSY0b637f58-5604-454d-99ba-24115113ac3d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-013-04561040013044 PATCH in 1 PACKAGE (56104-013-04) 4 patch2013-01-012027-06-30NoNoCurrent