FDA.reportPublic FDA data

Cornex

Product NDC
82160-238
11-digit product format
821600238
Labeler code
82160
Product ID
82160-238_e1de47ff-90a8-0b0d-e053-2a95a90a67c1
Type
HUMAN OTC DRUG
Nonproprietary name
Lactic Acid, Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Application
M030
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-03-25
Marketing end
0000-00-00
Substance
LACTIC ACID; SALICYLIC ACID
Active strength
2505 mg/15g; mg/15g
Pharmacologic classes
Acidifying Activity [MoA]
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 productproduct82160-238IInactivated by FDA2026-10-05
excluded packagepackage82160-23882160-238-01IInactivated by FDA2026-10-05

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
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82160-238-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82160-238-010efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-238-01Cornex15 g in 1 TUBEGEL15242
82160-238-01Cornex1 in 1 CARTONGEL1242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-238CORNEX (LACTIC ACID, SALICYLIC ACID) GEL [PELLA PHARMACEUTICALS CO. LTD]242Legacy NDC, 2 package rows20250123_d0d10aa0-063e-0160-e053-2995a90a3b88.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 6 · 106 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
244534lactic acid 16.7 % / salicylic acid 16.7 % Topical GelPSNd0d10aa0-063e-0160-e053-2995a90a3b88242
244534lactic acid 0.167 MG/MG / salicylic acid 0.167 MG/MG Topical GelSCDd0d10aa0-063e-0160-e053-2995a90a3b88242
244534lactic acid 16.7 % / salicylic acid 16.7 % Topical GelSYd0d10aa0-063e-0160-e053-2995a90a3b88242
244534lactic acid 167 MG / salicylic acid 167 MG per 1 GM Topical GelSYd0d10aa0-063e-0160-e053-2995a90a3b88242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82160-238-01821600238011 TUBE in 1 CARTON (82160-238-01) > 15 g in 1 TUBE1 tube2010-03-250000-00-00NoNoCurrent